510(k) Report

FDA applicant

Streck Laboratories, Inc.

Omaha, NE70 decisions1977–20049 recalls

FDA records 70 decisions for Streck Laboratories, Inc. (Omaha, NE) from 1977 to 2004: 70 510(k) clearances. Most are in product codes JPK (Mixture, Hematology Quality Control) and JJX (Single (Specified) Analyte Controls (Assayed…). Its devices cite 12 predicates, 7 of them its own earlier devices. 9 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Streck Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Streck Laboratories, Inc. since 2007.

Recalls per year

4in 2025

2010: 52025: 4
2007high 5 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Streck Laboratories, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Streck Laboratories, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • JPKMixture, Hematology Quality Control23decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)9decisions
  • JJYMulti-Analyte Controls, All Kinds (Assayed)7decisions
  • GGLControl, White-Cell4decisions
  • GLQMixture, Control, White-Cell And Red-Cell Indices4decisions
  • JCNControl, Cell Counter, Normal And Abnormal4decisions

Also: KRX (2), KRY (2), GHM (2), GJR (2), JKA (1), JOX (1).

Whose devices does it build on?

Its devices cite 12 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K000076Cell-ChexStreck Laboratories, Inc. · 20003cite it
  • K920997CD-ChexStreck Laboratories, Inc. · 19922cite it
  • K000115Retic Chex LinearityStreck Laboratories, Inc. · 20002cite it
  • K911582Stak-ChexStreck Laboratories, Inc. · 19912cite it
  • K960894CD-Chex + RBCStreck Laboratories, Inc. · 19962cite it
  • K840261Cal-Chex, a Hematology CalibratorStreck Laboratories, Inc. · 19842cite it

What has FDA decided for it lately?

  • K042587Retic-Chex for Cell-DynStreck Laboratories, Inc. · 2004
  • K040107Cyto-Chex BCTStreck Laboratories, Inc. · 2004
  • K040025A1C-CellularStreck Laboratories, Inc. · 2004
  • K023656Sickle-Chex Solubility KitStreck Laboratories, Inc. · 2002
  • K021922Modification to Para 5XStreck Laboratories, Inc. · 2002
  • K020469Cal-Chex CD PlusStreck Laboratories, Inc. · 2002
  • K013316Sickle-ChexStreck Laboratories, Inc. · 2001
  • K011410PARA 5XStreck Laboratories, Inc. · 2001

All 70 as Streck Laboratories, Inc. →

What has been recalled?

9 recalls linked to its devices; the latest:

  • K840261ADVIA¿ 120/2120/2120i SETpoint CalibratorJun 4, 2025Class II
  • K993825ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)Jun 4, 2025Class II
  • K993825ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)Jun 4, 2025Class II
  • K993825ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)Jun 4, 2025Class II
  • K913687Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog Number 12-712.…Oct 6, 2010
  • K913687Cholestech LDX Calibration Verification, Levels 1-4, Catalog Number 11-255. To be used…Oct 6, 2010

Other applicant names beginning “Streck”

FDA records each applicant name separately; these may or may not be the same firm.

Streck 38