510(k) Report

FDA applicant

Diagnostic Reagents, Inc.

Mountain View, CA66 decisions1982–19982 recalls

FDA records 66 decisions for Diagnostic Reagents, Inc. (Mountain View, CA) from 1982 to 1998: 66 510(k) clearances. Most are in product codes DLJ (Calibrators, Drug Specific) and DKB (Calibrators, Drug Mixture). 2 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 toxicology panel, where it files most

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

FDA decisions per year

No FDA decision for Diagnostic Reagents, Inc. since 2007.

Recalls per year

1in 2016

2013: 12016: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Diagnostic Reagents, 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?

  • DLJCalibrators, Drug Specific7decisions
  • DKBCalibrators, Drug Mixture6decisions
  • DJREnzyme Immunoassay, Methadone3decisions
  • DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites3decisions
  • LCMEnzyme Immunoassay, Phencyclidine3decisions
  • DISEnzyme Immunoassay, Barbiturate3decisions

Also: LDJ (2), JXM (2), KXT (2), KHQ (2), JIS (2), CDP (2).

Who builds on its devices?

Later devices cite its devices 37 times; 0 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.

  • K983159Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 19984cite it
  • K931780Methadone Metabolite Eia AssayDiagnostic Reagents, Inc. · 19933cite it
  • K943998Cannabinoid Eia AssayDiagnostic Reagents, Inc. · 19942cite it
  • K930529Benzodiazepine Enzyme ImmunoassayDiagnostic Reagents, Inc. · 19932cite it
  • K923783Ethyl Alcohol AssayDiagnostic Reagents, Inc. · 19932cite it
  • K935320Phencyclidine Eia AssayDiagnostic Reagents, Inc. · 19932cite it

What has FDA decided for it lately?

  • K983268Modification of Tricyclic Serum Tox Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983812Napa Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983323Digoxin ImmunoassayDiagnostic Reagents, Inc. · 1998
  • K983280Vancomycin Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983159Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998
  • K973102Lidocaine Eia AssayDiagnostic Reagents, Inc. · 1997
  • K97283550NG/ML Cocaine Metabolite CalibratorDiagnostic Reagents, Inc. · 1997
  • K972526Methadone Eia AssayDiagnostic Reagents, Inc. · 1997

All 66 as Diagnostic Reagents, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K961131DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate…Jul 25, 2016Class II
  • K960187DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott…Jul 23, 2013Class II

Other applicant names beginning “Diagnostic”

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

Diagnostic Products Corp. 324Diagnostic Systems Laboratories, Inc. 94Diagnostic Chemicals, Ltd. (Usa) 77Diagnostic 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