# Tosoh Medics, Inc.

- Location (FDA's records): South San Francisco, CA
- FDA decisions: 41 (1990–2002): 41 510(k) clearances
- Product codes: JJX (10), CDP (3), MMI (2), JZO (2), LTK (2), LCP (2), CGN (2), DHX (2), JFT (1), KHO (1), JLW (1), CDD (1)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 31 (2 its own)
- Recalls linked to its devices: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Diagnostic Products Corp.: 1 (https://510kreport.com/company/diagnostic-products)
- Helena Laboratories: 1 (https://510kreport.com/company/helena-laboratories)
- Bio-Rad: 1 (https://510kreport.com/company/bio-rad)
- Beckman Instruments, Inc.: 1 (https://510kreport.com/company/beckman-instruments)

## Firms that cite its devices most
- Boehringer Mannheim Corp.: 14 (https://510kreport.com/company/boehringer-mannheim)
- Tosoh Bioscience, Inc.: 6 (https://510kreport.com/company/tosoh-bioscience)
- bioMerieux, Inc.: 3 (https://510kreport.com/company/biomerieux)
- Seradyn, Inc.: 1 (https://510kreport.com/company/seradyn)
- Ortho-Clinical Diagnostics, Inc.: 1 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Siemens Medical Solutions Diagnostics: 1 (https://510kreport.com/company/siemens-medical-solutions-diagnostics)
- Bayer Diagnostics Corp.: 1 (https://510kreport.com/company/bayer-diagnostics)
- Axis-Shield Diagnostics, Ltd.: 1 (https://510kreport.com/company/axis-shield-diagnostics)

## Its most-cited devices
- K924862: Aia-Pack HCG Calibration Verification Test Set (1992), cited by 9
- K924863: Aia-Pack FSH Calibration Verification Test Set (1992), cited by 5
- K011434: G7 Automated HPLC Analyzer (2001), cited by 5
- K951848: Aia-Pack CPR Assay (1996), cited by 2
- K972265: A1C 2.2 Plus - Automated Glycohemoglobin Analyzer (1997), cited by 2
- K933269: Aia-Pack (R) Prog Assay (1993), cited by 2

## Recent decisions
- K023893: ST Aia-Pack Cea Enzyme Immunoassay (Dec 18, 2002)
- K023894: ST Aia-Pack Afp Enzyme Immunoassay (Dec 17, 2002)
- K023091: ST Aia-Pack Testosterone Assay (Dec 17, 2002)
- K023891: ST Aia-Pack CA 125 Enzyme Immunoassay (Dec 6, 2002)
- K020489: G7 Automated HPLC Analyzer, Beta-Thalassemia Mode (May 14, 2002)
- K012820: Aia-Pack Ctni 2ND-Gen Assay (Dec 14, 2001)
- K011434: G7 Automated HPLC Analyzer (Sep 18, 2001)
- K010796: Aia-Pack Brca, ST Aia Pack Brca (Aug 16, 2001)

Source page: https://510kreport.com/company/tosoh-medics