Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1950302

FEI Number

1950302

Entity Name

STRECK LLC

City/State/Country

La Vista, NE, US

Establishment Address

7002 SOUTH 109TH ST., La Vista, NE 68128, US

Establishment Type(s)

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

Owner / Operator

STRECK (Owner Number: 1950302)

Owner / Operator Contact Address

7002 SOUTH 109TH ST., --, La Vista, NE 68128, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143577

PMA Number

N/A

All Registered Proprietary Names

Cell-Chex CELL-DYN 29 Plus Control (w/Retics) Alinity h-series HemCal XN CAL XN CHECK BF Sperm-Chex Post VC Sperm-Chex TESTpoint Retic High Control (4 x 4 mL) TESTpoint Retic Low Control (4 x 4 mL) Sysmex e-CHECK XE XN-L CHECK CELL-DYN Retic Plus Control ESR-CHEX PLUS ESR-CHEX CSF Reagent (1 x 8 mL) CD-Chex CD34 CD-Chex Plus CD-Chex Plus CD4 Low Para 12 Extend Platelet CHECK WRP CHECK WRP CHECK EX 3-in-1 TESTpoint Hematology Abnormal Control 2 (4 x 4 mL) 3-in-1 TESTpoint Hematology Abnormal Control 1 (4 x 4 mL) 3-in-1 TESTpoint Hematology Normal Control (4 x 4 mL) Sysmex SCS-1000 Hematology Calibrator TESTpoint Hematology Low Control (4 x 4 mL) TESTpoint Hematology Normal Control (4 x 4 mL) TESTpoint Hematology High Control (4 x 4 mL) X-Cal XN CAL PF ClealLab Control Cells XN CHECK BF Advia SETpoint Hematology Calibrator (2 x 6.1 mL) XN CAL STaK-Chex Plus Retics CELL-DYN 18 Plus Control Retic-Chex Linearity for BC CELL-DYN 22 Plus Calibrator CELL-DYN 18 Plus Calibrator CELL-DYN 22 Plus Control XN CHECK BF XN CAL PF MDx-Chex for BCID2 EIGHTCHECK-3WP EIGHTCHECK-3WP X-TRA TESTpoint CSF Controls (2 x 3 mL) MDx-Chex for BC-GN XN CHECK XW QC CHECK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Hematology	Class 2	864.8625	2013-09-03
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Hematology	Class 2	864.8625	2007-10-31
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2014-12-23
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2014-12-23
NRF	Material, Quality Control, Semen Analysis	Hematology	Class 2	864.8625	2015-08-19
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2010-04-05
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2009-02-02
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2017-01-20
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2009-05-28
JPH	Test, Erythrocyte Sedimentation Rate	Hematology	Class 1	864.6700	1997-05-28
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2013-01-30
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	Class 2	864.5200	2013-01-30
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2013-01-30
GGL	Control, White-Cell	Hematology	Class 2	864.8625	2007-10-31
GGL	Control, White-Cell	Hematology	Class 2	864.8625	2007-10-31
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Hematology	Class 2	864.8625	2008-09-08
GJP	Control, Platelet	Hematology	Class 2	864.8625	2021-11-30
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-10-31
JCN	Control, Cell Counter, Normal And Abnormal	Hematology	Class 2	864.8625	2010-04-05
KSA	Calibrator For Red-Cell And White-Cell Counting	Hematology	Class 2	864.8185	2009-02-02
JCN	Control, Cell Counter, Normal And Abnormal	Hematology	Class 2	864.8625	2007-10-31
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2009-02-11
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2014-12-23
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2022-07-06
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2012-11-01
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2007-10-31
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2017-01-20
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Hematology	Class 2	864.8625	2009-03-26
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Hematology	Class 2	864.8625	2025-08-11
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-10-31
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2012-02-15
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2025-08-11
GLQ	Mixture, Control, White-Cell And Red-Cell Indices	Hematology	Class 2	864.8625	2012-02-15
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2017-01-20
KRX	Calibrator For Cell Indices	Hematology	Class 2	864.8150	2012-11-01
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2022-01-25
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2007-10-31
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2013-01-30
PMN	Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays	Microbiology	Class 2	866.3920	2023-08-08
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2017-01-20
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2018-02-15
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2018-02-15

Official Correspondent

Wendy Royalty

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STRECK

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017953151	STRECK LLC	La Vista, NE, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781077	Dade, Baxter Travenol Diagnostics, Inc.	CONTROL, HEMATOLOGY, CH-60	1978-07-27
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07
K052101	Roche Diagnostics	C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C	2005-08-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1950302. Last updated year: 2026. Please use registration number 1950302 when referencing this establishment in official correspondence.