Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1640981

FEI Number

1640981

Entity Name

SLMP LLC d.b.a. StatLab Medical Products

City/State/Country

McKinney, TX, US

Establishment Address

2090 Commerce Drive, McKinney, TX 75069, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

SLMP LLC (STATLAB MEDICAL PRODUCTS) (Owner Number: 10030272)

Owner / Operator Contact Address

2090 Commerce Dr., McKinney, TX 75069, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bouin's Solution StatLab Bouin Prefill GOLD CHLORIDE Fast Green Counterstain Methylene Blue Stain High Def 1% Acid Rinse Reserve Bluing Vintage Bluing Select Bluing Focus 0.5% Acid Alcohol High-Def Select Acid Rinse Focus 1% Acid Alcohol OG-6 Saccomanno Fluid StatLab Saccomanno Prefill Plus Alcohol 100% Isopropyl Alcohol Methanol RGA 95% Citra Clear Isopropyl Alcohol 70% Xylene Plus Alcohol 95% IsoClear XS-3 RGA 50% w/Type 1 Water RGA 70% w/ Type 1 Water RGA 80% RGA 100% WEIGERT'S HEMATOXYLIN StatLab Reagent CYTOLOID Mucolytic Reagent StatLab pH Buffer StatLab Quantum Slide Stainer Iron Hematoxylin, Solution Margin Marker Toluidine Blue Stock Solution Parapro ANILINE BLUE STAIN StatPrep Preserve StatPrep Cell Solution PrepCyte Preserve GYN, Prepcyte NON GYN Van Gieson's Stain StatLab Submount Acrymount 37% Formaldehyde StatLab GTF Prefill Prostate Biopsy Kit StatLab ANBF Prefill CytoVial StatLab AZF Prefill StatLab Biopsy Kit Optic Mount Acrymount PLUS StatLab Carson Millonig Prefill 10% Modified Carson/Millonig Buffered Zinc Formalin StatLab BFZ Prefill StatLab Hollandes Prefill StatLab Michels Fixative Prefill B-Fixative Zinc Formalin Concentrate StatLab BFix Prefill Formalin 10% Non-Buffered Formalin 20% NBF StatFix Harris Hematoxylin Hema-Diff # 1 Fixative Hema-Diff #3 Thiazine Hema-Diff #2 Xanthene Eosin Y Alcoholic Eosin with Phloxine B Vintage Eosin Reserve Eosin Multichrome Treosin Select Eosin Giemsa Stain

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ICN	Biebrich Scarlet	Hematology	Class 1	864.1850	2014-12-23
IGN	Fluid, Bouin'S	Pathology	Class 1	864.4010	2009-10-13
HYH	Gold Chloride	Hematology	Class 1	864.1850	2014-12-23
HYC	Fast Green	Hematology	Class 1	864.1850	2014-12-23
KFC	Methylene Blue, Tissue Stain	Hematology	Class 1	864.1850	2014-12-23
LED	Stains, Chemical Solution	Hematology	Class 1	864.1850	2013-12-26
HZH	Orange G	Hematology	Class 1	864.1850	2013-12-26
IFL	Polyethylene Glycol Preservative	Pathology	Class 1	864.4010	2013-12-26
KEM	Agent, Clearing	Pathology	Class 1	864.4010	2009-10-13
HYO	Hematoxylin Weigert'S	Hematology	Class 1	864.1850	2014-12-23
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2009-10-15
JCC	Ph Buffer	Pathology	Class 1	864.4010	2016-04-17
KPA	Slide Stainer, Automated	Pathology	Class 1	864.3800	2018-04-24
GGH	Iron Stains	Hematology	Class 1	864.1850	2014-12-23
LEE	Stains, Dye Solution	Hematology	Class 1	864.1850	2013-12-26
IAB	Toluidine Blue	Hematology	Class 1	864.1850	2014-12-23
KEO	Formulations, Paraffin, All	Pathology	Class 1	864.4010	2014-12-23
KFD	Aniline Blue	Hematology	Class 1	864.1850	2014-12-23
LEA	Preservative, Cytological	Pathology	Class 1	864.4010	2009-10-15
HZX	Silver Nitrate	Hematology	Class 1	864.1850	2014-12-23
IAC	Van Gieson'S Stain	Hematology	Class 1	864.1850	2014-12-23
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2014-12-19
KEQ	Media, Mounting, Water Soluble	Pathology	Class 1	864.4010	2009-10-13
IGG	Formaldehyde (Formalin, Formol)	Pathology	Class 1	864.4010	2011-12-15
LDZ	Fixative, Alcohol Containing	Pathology	Class 1	864.4010	2009-10-15
LDW	Fixative, Acid Containing	Pathology	Class 1	864.4010	2011-12-15
LEB	Mounting Media	Pathology	Class 1	864.4010	2009-10-13
LDY	Fixative, Formalin-Containing	Pathology	Class 1	864.4010	2009-10-13
HYK	Hematoxylin Harris'S	Hematology	Class 1	864.1850	2009-10-13
KQC	Stains, Hematology	Hematology	Class 1	864.1850	2013-12-26
HYB	Eosin Y	Hematology	Class 1	864.1850	2009-10-13
HYF	Giemsa Stain	Hematology	Class 1	864.1850	2014-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SLMP LLC (STATLAB MEDICAL PRODUCTS)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3029894046	SLMP LLC d.b.a. StatLab Medical Products	Arlington, TX, US
3021584593	Statlab Distribution Center	McKinney, TX, US

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
K791007	Bioscientific	STAT DIFF STAIN	1979-08-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2015	Richard-Allan Scientific Company	1	Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0013-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific Specimen Transportation System. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0014-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0015-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Z-0016-2015	Richard-Allan Scientific Company	1	Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1640981. Last updated year: 2026. Please use registration number 1640981 when referencing this establishment in official correspondence.