# Syva Co.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 448 (1976–2001): 448 510(k) clearances
- Product codes: LAS (22), DKB (21), DLJ (18), LDJ (17), KLI (14), DIS (13), DIF (13), DKZ (13), JXM (13), KLT (12), KLS (11), DIP (10)
- Predicates its devices cite: 7 (5 its own); citations of its devices by later devices: 41 (5 its own)
- Recalls linked to its devices: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Abbott Laboratories: 1 (https://510kreport.com/company/abbott-laboratories)
- Behring Diagnostics, Inc.: 1 (https://510kreport.com/company/behring-diagnostics)

## Firms that cite its devices most
- Abbott Laboratories: 9 (https://510kreport.com/company/abbott-laboratories)
- Dade Behring, Inc.: 6 (https://510kreport.com/company/dade-behring)
- Ortho-Clinical Diagnostics, Inc.: 5 (https://510kreport.com/company/ortho-clinical-diagnostics)
- Lin-Zhi International, Inc.: 3 (https://510kreport.com/company/lin-zhi-international)
- Biosite Incorporated: 2 (https://510kreport.com/company/biosite)
- Diagnostic Hybrids, Inc.: 2 (https://510kreport.com/company/diagnostic-hybrids)
- Microgenics Corp.: 2 (https://510kreport.com/company/microgenics)
- Behring Diagnostics, Inc.: 2 (https://510kreport.com/company/behring-diagnostics)

## Its most-cited devices
- K881040: Emit Vancomycin Assay (1988), cited by 2
- K853872: Emit Caffeine Assay (1986), cited by 2
- K993755: Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5 (1999), cited by 2
- K993985: Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129UL (2000), cited by 2
- K993988: Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029UL (2000), cited by 2
- K880157: Microtrak HSV 1/HSV 2 Culture Identi./Typing Test (1988), cited by 2

## Recent decisions
- K011878: Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators, Model 7S109UL (Aug 13, 2001)
- K012257: Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229 (Aug 3, 2001)
- K011947: Emit 2000 Valproic Acid Assay, Model OSR4G229UL (Jul 2, 2001)
- K011528: Emit 2000 Phenobarbital Assay, Model OSR4D229 (Jun 6, 2001)
- K011347: Emit 2000 Phenytoin Assay, Model 0SR4A229 (May 17, 2001)
- K993980: Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409UL (Feb 1, 2000)
- K993981: Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129UL (Feb 1, 2000)
- K993029: Abbott Aeroset Theophylline Assay and Calibrators; Models 1E09 and 6E89 (Jan 27, 2000)

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