SAKURA FINETEK U.S.A., INC.

FDA Device Registration & Listing · TORRANCE, CA, US · Registration 2083544

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2083544
FEI Number
2083544
Entity Name
SAKURA FINETEK U.S.A., INC.
City/State/Country
TORRANCE, CA, US
Establishment Address
1750 W 214th St, TORRANCE, CA 90501, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Sakura Global Holding Company (Owner Number: 8031662)
Owner / Operator Contact Address
1750 W 214th St, Torrance, CA 90501, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Tissue-Tek VIP 6 AI Tissue-Tek VIP 6 Histo-Tek VP1 TISSUE-TEK XPRESS Tissue-Tek VIP Tissue-Tek Xpress X120 Tissue-Tek Xpress X50 Tissue-Tek Prisma® H&E Stain Kit #1 Tissue-Tek Prisma® H&E Stain Kit #2 Tissue-Tek Cold Plate TISSUE-TEK CRYO CONSOLE Tissue-Tek VIP Fixative Tissue-Tek Clearfix Fixative Tissue-Tek Glas Mounting Medium Tissue-Tek® anti-Treponema pallidum Rabbit Polyclonal Antibody Tissue-Tek® anti-Cytomegalovirus Antibody Cocktail [DDG9/CCH2] Tissue-Tek® anti-Procollagen-1 Rat Monoclonal Antibody [M-58] Genemed HER2 Red and Chromosome 17 Centromere Green FISH Probe Cocktail, 100 uL Genemed Rabbit anti-ER, Clone EP1, Ready-To-Use, 7 mL Genemed Rabbit Monoclonal anti-EGFR Antibody. Clone GR018, Concentrate, 1 mL Genemed Rabbit anti-HER-2 (c-erbB-2), Clone GR011, Ready-To-Use, 7 mL Genemed EBER, DIG-Labeled Probe, Ready-To-Use, 400 uL Genemed Mouse anti-ER, Clone GM029, Concentrate, 0.5 mL Genemed HER2 Green and Chromosome 17 Centromere Red FISH Probe Cocktail, Ready-To-Use, 100 uL Genemed Rabbit Monoclonal anti-Progesterone Receptor (PR), Clone Y85, Concentrate, 1 mL Genemed Rabbit Monoclonal Anti-Estrogen Receptor (ER) alpha positive cells, Clone GR001, Concentrate, 1 mL Genemed Rabbit Monoclonal anti-EGFR Antibody. Clone GR018, Concentrate, 0.5 mL Genemed Mouse anti-ER, Clone 1D5, Ready-To-Use, 7 mL Genemed EGFR Green and Chromosome 7 Centromere Red FISH Probe, Ready-To-Use, 100 uL Genemed Rabbit anti-HER2 (c-erbB-2), Clone GR011, Concentrate, 1 mL Tissue-Tek® anti-Herpes Simplex Virus 2 Rabbit Polyclonal Antibody Tissue-Tek® anti-Herpes Simplex Virus 1 Rabbit Polyclonal Antibody Tissue-Tek® anti-p16 Mouse Monoclonal Antibody [MX007] Genemed Rabbit Monoclonal anti-Progesterone Receptor (PR), Clone Y85, Concentrate, 0.2 mL Genemed Rabbit anti-ER, Clone EP1, Concentrate, 0.2 mL Genemed Chromosome 17 Centromere Probe, DIG-Labeled, Ready-To-Use, 400 uL Tissue-Tek® anti-HER2 Rabbit Monoclonal Antibody [GR011] Genemed Chromosome 3 Centromere, DIG-Labeled Probe, Ready-To-Use, 400 uL Genemed Rabbit anti-HER2 (c-erbB-2), Clone GR011, Concentrate, 0.5 mL Genemed Rabbit anti-ER, Clone EP1, Concentrate, 0.5 mL Tissue-Tek® anti-Estrogen Receptor ? Rabbit Monoclonal Antibody [EP1] Genemed Chromosome 7 Centromere, DIG-Labeled Probe, Ready-To-Use, 400 uL Genemed Rabbit anti-HER2 (c-erbB-2), Clone GR011, Concentrate, 0.2 mL Genemed Rabbit Monoclonal Anti-Estrogen Receptor (ER) alpha positive cells, Clone GR001, Concentrate, 0.2 mL Genemed Rabbit Monoclonal anti-Progesterone Receptor (PR), Clone Y85, Ready-To-Use, 7 mL Genemed Rabbit Monoclonal anti-EGFR Antibody. Clone GR018, Concentrate, 0.2 mL Genemed Rabbit Monoclonal anti-EGFR Antibody. Clone GR018, Ready-To-Use, 7 mL Genemed Chromosome X Centromere Probe, DIG-Labeled, Ready-To-Use, 400 uL Tissue-Tek® anti-Progesterone Receptor Rabbit Monoclonal Antibody [Y85] Genemed Rabbit Monoclonal Anti-Estrogen Receptor (ER) alpha positive cells, Clone GR001, Concentrate, 0.5 mL Genemed Rabbit Monoclonal Anti-Estrogen Receptor (ER) alpha positive cells. Clone GR001, Ready-to-use, 7 mL Genemed HER2 CISH DIG-Labeled Probe, Ready-To-Use, 400 uL Genemed Mouse anti-ER, Clone GM029, Concentrate, 1 mL Genemed TERC Red and Chromosome 3 Centromere Green FISH Probe Cocktail, Ready-To-Use, 100 uL Genemed Rabbit Monoclonal anti-Progesterone Receptor (PR), Clone Y85, Concentrate, 0.5 mL Genemed Rabbit anti-ER, Clone EP1, Concentrate, 1 mL Genemed Mouse anti-ER, Clone GM029, Concentrate, 0.2 mL Genemed® anti-HER2 Rabbit Monoclonal Antibody [GR011], RTU, 15 mL Genemed® anti-Estrogen Receptor ? Rabbit Monoclonal Antibody [EP1], RTU, 15 mL Genemed® anti-Cytomegalovirus (CMV) Mouse Monoclonal Antibody [DDG9/CCH2], RTU, 15 mL Genemed® anti-Progesterone Receptor Rabbit Monoclonal Antibody [Y85], RTU, 15 mL Genemed® anti-p16 Mouse Monoclonal Antibody [MX007], RTU, 15 mL Genemed® anti-Herpes Simplex Virus 2 (HSV2) Rabbit Polyclonal Antibody, RTU, 15 mL Genemed® anti-Herpes Simplex Virus 1 (HSV1) Rabbit Polyclonal Antibody, RTU, 15 mL Genemed® anti-Procollagen I Rat Monoclonal Antibody [M-58], RTU, 15 mL Genemed® anti-ALK (Lung) Mouse Monoclonal Antibody [1A4] Genemed® anti-Treponema Pallidum Rabbit Polyclonal Antibody, RTU, 15 mL Genemed® CISH Positive Control Ready-To-Use Genemed CISH Lambda Probe Ready-To-Use Genemed® anti-PD-L1 Rabbit Monoclonal Antibody [RM320] Ready-To-Use, 15 mL Genemed® ISH Kappa Probe RTU, 1 bottle, 15 mL Genemed® CISH Negative Control Ready-To-Use Genemed® CISH Amplification Linker Ready-To-Use Genemed® CISH EBER Probe RTU, 1 bottle, 15 mL Genemed® anti-HER2 Rabbit Monoclonal Antibody [EP3]; RTU, 15 mL Genemed® CISH mRNA Negative Control, 30 tests Genemed® CISH mRNA Positive Control ,30 tests Genemed® CISH Kappa Probe, 30 tests Tissue-Tek Genie® Reagent Dispense Area Tissue-Tek Genie® Wash Buffer Tissue-Tek Genie® Dewax Solution Tissue-Tek Genie® Slide Label Kit Tissue-Tek Genie® RDA-Tag Label Kit Tissue-Tek Genie® Reagent Dispense Area Tag Tissue-Tek Genie® High pH Antigen Retrieval Solution Tissue-Tek Genie® Citrate Antigen Retrieval Solution Tissue-Tek Genie® Antibody Diluent Genemed Power-Stain™ 1 Kit Poly HRP AEC Kit for Mouse + Rabbit, Ready-To-Use, 15 mL Genemed Proteinase K, Ready-To-Use, 50 mL Genemed Acu-Stain™ Mouse + Rabbit, Ready-To-Use, 125 mL Genemed Peroxidase Blocking Solution, Ready-To-Use, 100 mL Genemed Mayer's Hematoxylin, Ready-To-Use, 100 mL Genemed Citrate Buffer pH 6 (20X), Concentrate, 100 mL Genemed AP Streptavidin Conjugate, 1 mL Genemed AEC Substrate (Single Solution), Ready-To-Use, 15 mL Tissue-Tek Genie® User-Fillable Cartridge for Biomarker-Binding Reagent Genemed Tris EDTA Buffer pH 9 (20X), Concentrate, 100mL Xpress Processing reagent Genemed PBS Powder, 2 pouches (1 L of 10X per pouch) Genemed Primary Antibody Diluent, Ready-To-Use, 500 mL Genemed Power-Stain™ 1 Double Stain Kit I (Poly HRP for Mouse + Poly AP for Rabbit), Ready-To-Use, 15 mL Tissue-Tek® Mold Release Genemed Mini PAP Pen, ea Genemed SSC Buffer (20X), 100 mL Genemed C-Block (Casein Blocking Solution), Ready-To-Use, 100mL Genemed Power-Stain™ 1 Kit Poly HRP DAB for Mouse + Rabbit, Ready-To-Use, 100mL Genemed Sensitive DAB Substrate Kit, 200 mL Genemed Power-Stain™ 1 Kit Poly HRP DAB for Mouse + Rabbit, Ready-To-Use, 15mL Genemed Power-Stain™ 1 Poly AP Kit for Mouse and Rabbit, 15 mL Genemed CleanMount™ Aqueous Mounting Solution, 15mL Genemed Acu-Stain™ Mouse + Rabbit HRP Kit, Ready-To-Use, 15 mL Genemed Citrate Buffer pH 6 (1X), Ready-To-Use, 1000 mL Genemed AEC Substrate (Single Solution), Ready-To-Use, 100 mL Genemed Tris EDTA Buffer pH 9 (1X), Ready-To-Use, 1000mL Genemed GVA Aqueous Mounting Solution, 15mL Genemed Antibody Diluent for Automated Stainers, Ready-To-Use, 500mL Genemed Super PAP Pen, ea Genemed Power-Stain™ 1 Kit Poly HRP AEC Kit for Mouse + Rabbit, Ready-To-Use, 100 mL Genemed TBST (Tris Buffered Saline and 05% Tween 20), pH 7.4 (20X), concentrate, 100 mL Genemed A/B Block (Avidin/Biotin Blocking Solution), Ready-To-Use, 15mL Genemed Power-Stain™ 2 Kit Poly HRP for Mouse + Rabbit, Ready-To-Use, 15mL Genemed Power-Stain™ 2 Kit Poly HRP for Mouse + Rabbit, Ready-To-Use, 100mL Genemed Blocking Solution (Non-immune), 100 mL Tissue-Tek Xpress X120 Processing Tissue-Tek® Xylene Tissue-Tek Xpress X50 Processing Xpress Pre-Processing Tissue-Tek Genie® Pro Antibody Diluent Tissue-Tek® Reagent Alcohol 95% v/v Tissue-Tek® Reagent Alcohol 100% Tissue-Tek® 10% Neutral Buffered Formalin Tissue-Tek® Reagent Alcohol 70% v/v Genemed® SSC Stringent Wash Buffer RTU, 1 bottle, 3.8L Cyto-Tek 2500 CYTO-TEK CENTRIFUGE Tissue-Tek Prisma Plus Automated Slide Stainer Tissue-Tek Genie® Advanced Stainer, and Accessories Histo-Tek Mini Stainer Tissue-Tek Prisma Automated Stainer TISSUE-TEK DRS 2000 A Histo-Tek SL Tissue-Tek® Accu-Edge® Replaceable Blade Scissors Tissue-Tek® Accu-Edge® Replaceable Blade, Sharp/ Sharp; 5/case Tissue-Tek® Accu-Edge® Replaceable Blade, Blunt/ Blunt; 5/case Tissue-Tek® Accu-Edge® Replaceable Blade, Sharp/ Blunt; 5/case Tissue-Tek Accu-Edge Replaceable blade Scissors Mentip Hospital Cotton Swabs BD™ Sterile Swabs CA Tissue-Tek Xpress Molecular Fixative Tissue-Tek Molecular solution Tissue-Tek Cryo3 Plus Cryostat Tissue-Tek Cryo3 Flex Cryostat Tissue-Tek Cryo3 Microtome Tissue-Tek® Accu-Edge® Dissecting Scalpel Blades #61, Curved Tip Tissue-Tek® Accu-Edge®Trimming Blade, 5 inches Tissue-Tek® Accu-Edge® Trimming Knife Handle Tissue-Tek® Accu-Edge® Dissecting Scalpel Handle Tissue-Tek® Accu-Edge® Dissecting Scalpel Blades #62, Pointed Tip Tissue-Tek® Accu-Edge® Autopsy Blade, 100 mm; 5/case Accu-Edge® High Profile Blade Dispenser; 500/case Accu-Edge® Low Profile Blade Dispenser; 500/case Tissue-Tek® Accu-Edge® Brain Blade, 325 mm; 5/case Tissue-Tek® Accu-Edge® Trimming Blades, Long; 50/case Tissue-Tek® Accu-Edge® Trimming handle, Long Straight Tissue-Tek® Accu-Edge® Autopsy Blade, 170 mm; 5/case Tissue-Tek® Accu-Edge® Autopsy Knife Handle Histo-Tek® Biopsy Bags Tissue-Tek Lab Aid Filing Cabinet System Tissue-Tek Lab Aid Ultra II Cabinets Tissue-Tek® Biopsy Bags Tissue-Tek Paraforrn Processing/Embedding Medium Tissue-Tek V.I.P. Processing/Embedding Medium VisionTek VisionTek M6 Tissue-Tek Embedding Rings Tissue-Tek Nanomold Basemolds Tissue-Tek Base Mold Tissue-Tek Quick-Ray Microarray Kit Cryomold Tissue-Tek® SmartWrite® Green Frosted Slides 9053 Tissue-Tek® SmartWrite® Yellow Frosted Slides Tissue-Tek® SmartWrite® Lavender Frosted Slides Tissue-Tek® SmartWrite® Pink Frosted Slides Tissue-Tek® SmartWrite® Yellow Frosted Slides - Charged Tissue-Tek® SmartWrite® Blue Frosted Slides Tissue-Tek® SmartWrite® Blue Frosted Slides- Charged Tissue-Tek® SmartWrite® Lavender Frosted Slides - Charged Tissue-Tek® SmartWrite® Green Frosted Slides - Charged Tissue-Tek® SmartWrite® Pink Frosted Slides - Charged Tissue-Tek® SmartWrite® White Slide Tissue-Tek® SmartWrite® White Slide - Charged Tissue-Tek SmartWrite Slide Printer Tissue-Tek SmartWrite Cassette Printer with AutoLoader Tissue-Tek Grossing Board Tissue-Tek SmartWrite Cassette Printer Tissue-Tek Genie® Controller System Tissue-Tek X-CHEQ™ C Automated Cassette Tracking System TISSUE-TEK SLIDE STAINING SET Tissue-Tek AutoTEC® a120 Tissue-Tek AutoTEC® Tissue-Tek® TEC™6 Tissue-Tek® TEC™5

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IEO Processor, Tissue, Automated Pathology Class 1 864.3875 2003-07-28
HZT Reagent, Schiff Hematology Class 1 864.1850 2018-04-13
MXT Device, Accessory, Cooling Plate For Tissue Embedding Station Pathology Class 1 864.3010 2003-07-28
IFP Formalin, Neutral Buffered Pathology Class 1 864.4010 2011-01-05
LEB Mounting Media Pathology Class 1 864.4010 2011-01-05
MVU Reagents, Specific, Analyte Pathology Class 1 864.4020 2017-06-20
PPM General Purpose Reagent Pathology Class 1 864.4010 2001-04-14
IFB Cytocentrifuge Pathology Class 1 864.3300 2003-07-28
KPA Slide Stainer, Automated Pathology Class 1 864.3800 1989-05-26
JOK Scissors, Medical, Disposable General Hospital Class 1 880.6820 1995-02-14
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2020-04-06
LDZ Fixative, Alcohol Containing Pathology Class 1 864.4010 2011-01-05
IDP Microtome, Cryostat Pathology Class 1 864.3010 1996-01-05
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2019-08-12
NNK Container, Specimen Mailer And Storage, Non-Sterile Pathology Class 1 864.3250 2019-12-03
KEO Formulations, Paraffin, All Pathology Class 1 864.4010 2011-01-05
IBJ Light, Microscope Pathology Class 1 864.3600 2013-02-01
KER Container, Embedding Pathology Class 1 864.3010 1995-02-03
KEW Slides, Microscope Pathology Class 1 864.3010 1995-02-14
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2003-12-17
KIO Slide Stainer, Immersion Type Pathology Class 1 864.3800 2001-04-14
IDW Dispensers, Paraffin Pathology Class 1 864.3010 2003-07-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sakura Global Holding Company
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9614585 SAKURA FINETEK EUROPE B.V. Alphen aan den Rijn Zuid-Holland, NL
9680927 SAKURA FINETEK JAPAN CO., LTD Tokyo, JP
1000303355 SAKURA SEIKI CO., LTD. CHIKUMA-CITY Nagano, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K761138 Zeus Scientific, Inc. FA TISSUE FIXATIVE & WASH SET 1978-01-06
K842913 E K Ind., Inc. WRIGHT STAIN FIXATIVE 1984-09-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0039-2018 Teleflex Medical 1
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2083544. Last updated year: 2026. Please use registration number 2083544 when referencing this establishment in official correspondence.
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