510(k) Report

FDA applicant

Diagnostic Systems Laboratories, Inc.

Webster, TX94 decisions1981–200619 recalls

FDA records 94 decisions for Diagnostic Systems Laboratories, Inc. (Webster, TX) from 1981 to 2006: 94 510(k) clearances. Most are in product codes CFL (Radioimmunoassay, Human Growth Hormone) and JKC (Radioimmunoassay, Dehydroepiandrosterone (Free…). Its devices cite 1 predicate, 1 of them its own earlier devices. 19 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, clinical chemistry panel, where it files most

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

FDA decisions per year

No FDA decision for Diagnostic Systems Laboratories, Inc. since 2007.

Recalls per year

3in 2025

2009: 22010: 62011: 52012: 12025: 3
2007high 6 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • CFLRadioimmunoassay, Human Growth Hormone10decisions
  • JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)7decisions
  • CDZRadioimmunoassay, Testosterones And Dihydrotestosterone7decisions
  • CEWRadioimmunoassay, Parathyroid Hormone6decisions
  • CIZRadioimmunoassay, Androstenedione4decisions
  • JKRRadioimmunoassay, Calcitonin4decisions

Also: CGR (3), CGI (3), JHI (3), CHP (3), CKG (3), JZG (3).

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K960171Active Crosslaps ElisaDiagnostic Systems Laboratories, Inc. · 19961cites it
  • K952281Active Free Testosterone RiaDiagnostic Systems Laboratories, Inc. · 19951cites it
  • K850141Active Cortisol DSL 2000-SPDiagnostic Systems Laboratories, Inc. · 19851cites it
  • K002128Active Inhibin-a Elisa, Model DSL-10-28100Diagnostic Systems Laboratories, Inc. · 20001cites it
  • K971823Active Testosterone Eia (DSL-10-4000)Diagnostic Systems Laboratories, Inc. · 19971cites it
  • K896294DSL I-PTH (DSL #8000)Diagnostic Systems Laboratories, Inc. · 19891cites it

What has FDA decided for it lately?

  • K061758Active Renin IrmaDiagnostic Systems Laboratories, Inc. · 2006
  • K020945Axsym Intact PTH, Model 2G06Diagnostic Systems Laboratories, Inc. · 2002
  • K020128Active Free Beta-HCG Elisa, Model DSL-10-8500Diagnostic Systems Laboratories, Inc. · 2002
  • K002128Active Inhibin-a Elisa, Model DSL-10-28100Diagnostic Systems Laboratories, Inc. · 20004 recalls
  • K001086Free Testosterone Enzyme Immunoassay, Model DSL-10-4900Diagnostic Systems Laboratories, Inc. · 2000
  • K990138DSL Active Afp Elisa, Model DSL-10-8400Diagnostic Systems Laboratories, Inc. · 1999
  • K981871C-Reactive Protein Elisa, Model Number DSL-10-42100Diagnostic Systems Laboratories, Inc. · 1998
  • K973243Active Psa Elisa (DSL-10-9700)Diagnostic Systems Laboratories, Inc. · 1998

All 94 as Diagnostic Systems Laboratories, Inc. →

What has been recalled?

19 recalls linked to its devices; the latest:

  • K935013Estrone RIA, REF: DSL8700Dec 15, 2025Class II
  • K935013Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro…Jun 12, 2025Class II
  • K935013Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement…Jun 12, 2025Class II
  • K981607Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100…Jan 20, 2012Class II
  • K002128Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-4 The…Mar 31, 2011
  • K002128Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-1 The…Mar 31, 2011

Other applicant names beginning “Diagnostic”

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

Diagnostic Products Corp. 324Diagnostic Chemicals, Ltd. (Usa) 77Diagnostic Reagents, Inc. 66Diagnostic Chemicals, Ltd. 66Diagnostic Hybrids, Inc. 37Diagnostic Technology, Inc. 28Diagnostic Solutions, Inc. 26Diagnostic Ultrasound Corp. 16Diagnostic Systems 14Diagnostic Reagent Tech. 10Diagnostic Specialties 8Diagnostic Monitoring Software 5