# Syva Co., Dade Behring, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 19 (2000–2001): 19 510(k) clearances
- Product codes: KXS (1), LCD (1), KLI (1), LCM (1), DJG (1), DIC (1), KXT (1), DIS (1), LBZ (1), KLB (1), KLS (1), DIO (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 9 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Ortho-Clinical Diagnostics, Inc.: 4 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Dade Behring, Inc.: 3 (https://510kreport.com/company/dade-behring)
- Lin-Zhi International, Inc.: 1 (https://510kreport.com/company/lin-zhi-international)
- Ark Diagnostics, Inc.: 1 (https://510kreport.com/company/ark-diagnostics)

## Its most-cited devices
- K010960: Emit II Plus Ethyl Alcohol Assay, Model OSR9K229 (2001), cited by 2
- K011289: Emit II Plus Opiate Assay, Model OSR9B229 (2001), cited by 1
- K010934: Emit II Plus Barbituate Assay, Model 0SR9D0229 (2001), cited by 1
- K003341: Emit 2000 Tobramycin Assay Emit 2000 Tobramycin Calibrators (2001), cited by 1
- K011162: Modification to the Emit II Plus Cocaine Metabolite Assay (2001), cited by 1
- K010814: Emit 2000 Carbamazepine Assay, Model OSR4F229 (2001), cited by 1

## Recent decisions
- K011920: Emit 2000 Digoxin Assay, Model OSR4H229 (Jul 2, 2001)
- K011620: Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229 (Jun 18, 2001)
- K011605: Emit 2000 Quinidine Assay, Model OSR4Q229 (Jun 12, 2001)
- K011300: Emit II Plus Cannabinoid Assay, Model OSR9N229 (May 17, 2001)
- K011306: Emit II Plus Benzodiazepine Assay, Model 0SR9F229 (May 16, 2001)
- K011161: Modification to the Emit II Plus Phencyclidine Assay, Model OSR9J229 (May 15, 2001)
- K011289: Emit II Plus Opiate Assay, Model OSR9B229 (May 15, 2001)
- K011164: Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229 (May 10, 2001)

Source page: https://510kreport.com/company/syva-co-dade-behring