# Wyntek Diagnostics, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 12 (1995–2000): 12 510(k) clearances
- Product codes: JHI (5), LCX (3), GTY (1), JJX (1), GTZ (1), KTN (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 10 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Alfa Scientific Designs, Inc.: 3 (https://510kreport.com/company/alfa-scientific-designs)
- Chemtron Biotech, Inc.: 2 (https://510kreport.com/company/chemtron-biotech)
- SEKISUI Diagnostics, LLC: 1 (https://510kreport.com/company/sekisui-diagnostics)
- Instrumentation Laboratory CO: 1 (https://510kreport.com/company/instrumentation-laboratory)
- Lia Diagnostics: 1 (https://510kreport.com/company/lia-diagnostics)
- Binax, Inc.: 1 (https://510kreport.com/company/binax)
- Scripps Laboratories, Inc.: 1 (https://510kreport.com/company/scripps-laboratories)

## Its most-cited devices
- K953383: Wyntek Osom HCG-Urine Test (1995), cited by 3
- K990578: Osom Card II HCG-Urine Test, Model 102 (1999), cited by 2
- K972231: Osom Mono Test 143 (1997), cited by 2
- K992658: Osom Ultra Strep a Test, Model 147 (2000), cited by 1
- K974159: Osom HCG-Urine Test Model 101 (1997), cited by 1
- K954178: Osom Pregnancy Test (1995), cited by 1

## Recent decisions
- K992658: Osom Ultra Strep a Test, Model 147 (Jan 18, 2000)
- K990578: Osom Card II HCG-Urine Test, Model 102 (Mar 9, 1999)
- K990576: Osom Card Pregnancy Test, Model 103 (Mar 9, 1999)
- K974159: Osom HCG-Urine Test Model 101 (Dec 24, 1997)
- K973879: Osom Card HCG-Urine Test (Nov 4, 1997)
- K972231: Osom Mono Test 143 (Aug 26, 1997)
- K965227: Osom Classic HCG-Urine Test (115) (Feb 4, 1997)
- K965184: Perfecta Pregnancy Test (Feb 4, 1997)

Source page: https://510kreport.com/company/wyntek-diagnostics