Data / Medical devices / United States / Streck LLC
Streck LLC: FDA-registered device maker in La Vista, NE, United States, 22 510(k) clearances
Streck LLC is registered with the FDA (registration 1950302) in La Vista, NE, United States. It lists 19 device types. The FDA files 22 510(k) clearances under its listings, the newest dated July 27, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1950302
- Address
- 7002 South 109TH ST., La Vista, NE, United States, 68128
- Owner or operator
- STRECK (1950302)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- May 28, 1997
- Registered through
- 2026
- Brand names listed
- 3-in-1 TESTpoint Hematology Abnormal Control 1 (4 x 4 mL), 3-in-1 TESTpoint Hematology Abnormal Control 2 (4 x 4 mL), 3-in-1 TESTpoint Hematology Normal Control (4 x 4 mL), Advia SETpoint Hematology Calibrator (2 x 6.1 mL), Alinity h-series HemCal, Beckman Coulter iQ Body FLuids, CD-Chex CD34, CD-Chex Plus and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 27, 2023 | K231223 | MDx-Chex for BC-GN | PMN | Substantially Equivalent | Streck | accessdata.fda.gov |
| July 27, 2023 | K231221 | MDx-Chex for BC-GP | PMN | Substantially Equivalent | Streck | accessdata.fda.gov |
| January 19, 2022 | K212576 | MDx-Chex for BCID2 | PMN | Substantially Equivalent | Streck, Inc. | accessdata.fda.gov |
| August 7, 2020 | DEN200001 | Cell-Free DNA BCT | QMA | Unknown | Streck, Inc. | accessdata.fda.gov |
| October 12, 2015 | K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECK | GKZ | Substantially Equivalent | Sysmex America, Inc. | accessdata.fda.gov |
| August 23, 2010 | K101335 | CELL-CHEX | GLQ | Substantially Equivalent | Streck | accessdata.fda.gov |
| March 18, 2009 | K090137 | STAK-CHEX PLUS RETICS | GLQ | Substantially Equivalent | Streck | accessdata.fda.gov |
| February 3, 2009 | K083200 | X-CAL | KRX | Substantially Equivalent | Streck | accessdata.fda.gov |
| July 31, 2008 | K080552 | CYTO-CHEX BCT | GIM | Substantially Equivalent | Streck | accessdata.fda.gov |
| February 23, 2007 | K070199 | RETIC-CHEX LINEARITY FOR BC | JPK | Substantially Equivalent | Streck | accessdata.fda.gov |
| June 2, 2004 | K041240 | SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED | NRF | Substantially Equivalent | Fertility Solutions, Inc. | accessdata.fda.gov |
| December 30, 2002 | K023656 | SICKLE-CHEX SOLUBILITY KIT | GHM | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| November 6, 2001 | K013316 | SICKLE-CHEX | GHM | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| January 14, 2000 | K994388 | XE CHECK | GLQ | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| November 30, 1999 | K993825 | PARA TECH PLUS RETICS | JCN | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| November 26, 1999 | K993126 | CD-CHEX CD 34 | GGL | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| November 22, 1999 | K992887 | STAK-CHEX PLUS RETICS | GLQ | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| May 24, 1996 | K960894 | CD-CHEX + RBC | GGL | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| December 15, 1994 | K943268 | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) | KSA | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| February 20, 1991 | K905524 | RETIC-CHEX | JPK | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| May 30, 1990 | K901875 | PARA 12 PLUS | JCN | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
| December 28, 1982 | K823498 | PARA 12 | GLQ | Substantially Equivalent | Streck Laboratories, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 23, 2017 | 76501 | Class II | Ongoing | Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck. | Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers. | accessdata.fda.gov |
Compare with other makers
- All makers of Mixture, Hematology Quality Control
- All makers of Calibrator For Red-Cell And White-Cell Counting
- All makers of Calibrator For Cell Indices
- All makers of Counter, Differential Cell
- All makers of Counter, Cell, Automated (Particle Counter)
- All makers of Control, Cell Counter, Normal And Abnormal
Updated July 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.