# Microgenics Corp.

- Location (FDA's records): Concord, CA
- FDA decisions: 128 (1985–2024): 126 510(k) clearances and 2 De Novo grants
- Names in FDA's records: Microgenics Corp. (107); Microgenics Corporation (21)
- Product codes: DJG (13), KXT (9), DKZ (8), JXM (7), DKB (6), KLI (6), JJY (6), DIO (6), DLJ (5), LAS (5), LDJ (5), DIS (4)
- 510(k) review time since 2016: median 134 days, against 134 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 52 (19 its own); citations of its devices by later devices: 63 (19 its own)
- Recalls linked to its devices: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- OraSure Technologies, Inc.: 6 (https://510kreport.com/company/orasure-technologies)
- Diagnostic Reagents, Inc.: 5 (https://510kreport.com/company/diagnostic-reagents)
- Medical Analysis Systems, Inc.: 4 (https://510kreport.com/company/medical-analysis-systems)
- Boehringer Mannheim Corp.: 3 (https://510kreport.com/company/boehringer-mannheim)
- Bio-Rad Laboratories, Inc.: 3 (https://510kreport.com/company/bio-rad-laboratories)
- Abbott Laboratories: 2 (https://510kreport.com/company/abbott-laboratories)
- Syva Co.: 2 (https://510kreport.com/company/syva)
- Bio-Rad: 1 (https://510kreport.com/company/bio-rad)

## Firms that cite its devices most
- Boehringer Mannheim Corp.: 12 (https://510kreport.com/company/boehringer-mannheim)
- Immunalysis Corporation: 6 (https://510kreport.com/company/immunalysis)
- Lin-Zhi International, Inc.: 6 (https://510kreport.com/company/lin-zhi-international)
- Biophor Diagnostics, Inc.: 5 (https://510kreport.com/company/biophor-diagnostics)
- Siemens Healthcare Diagnostics, Inc.: 3 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- Dade Behring, Inc.: 2 (https://510kreport.com/company/dade-behring)
- Tianjin New Bay Bioresearch Co., Ltd.: 2 (https://510kreport.com/company/tianjin-new-bay-bioresearch)
- Thermo Fisher Scientific: 1 (https://510kreport.com/company/thermo-fisher-scientific)

## Its most-cited devices
- K040316: Cedia Buprenorphine Assay (2004), cited by 6
- K040411: Dri Oxycodone Assay (2004), cited by 4
- K001178: Cedia Dau 6-Acetylmorphine Assay (2000), cited by 4
- K012110: Dri Ecstasy Enzyme Immunoassay (2001), cited by 3
- K012109: Dri Ecstasy Urine Calibrators (2001), cited by 2
- K150502: DRI Hydrocodone Assay, DRI Hydrocodone Calibrators,  DRI Hydrocodone Controls (2015), cited by 2

## Recent decisions
- K243498: Alinity c Benzodiazepines Reagent Kit (Dec 11, 2024)
- K240670: DRI Ecstasy Plus Assay (Oct 30, 2024)
- K231020: Alinity c Tricyclic Antidepressants Reagent Kit (Nov 17, 2023)
- K231007: CEDIA Heroin Metabolite (6-AM) Assay (Sep 27, 2023)
- K213875: DRI TM Tricyclics Serum Tox Assay (Dec 21, 2022)
- K211973: DRI Cocaine Metabolite Assay (Sep 24, 2021)
- K192943: CEDIA Heroin Metabolite (6-AM) assay (Dec 16, 2019)
- K190968: CEDIA Benzodiazepine Assay (Dec 9, 2019)

Source page: https://510kreport.com/company/microgenics