Syva Co., Dade Behring, Inc.
Medical device manufacturer in Cupertino, CA.
19510(k) clearances
0PMA approvals
0recalls
Device types
- JXN Enzyme Immunoassay, Propoxyphene 1
- KXT Enzyme Immunoassay, Digoxin 1
- LAN Enzyme Immunoassay, N-Acetylprocainamide 1
- LBZ Enzyme Immunoassay, Quinidine 1
- LDJ Enzyme Immunoassay, Cannabinoids 1
- JXM Enzyme Immunoassay, Benzodiazepine 1
- DJG Enzyme Immunoassay, Opiates 1
- LCM Enzyme Immunoassay, Phencyclidine 1
- KLS Enzyme Immunoassay, Theophylline 1
- KXS Radioimmunoassay, Methaqualone 1
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 1
- DIO Enzyme Immunoassay, Cocaine And Cocaine… 1
- DJR Enzyme Immunoassay, Methadone 1
- DIC Alcohol Dehydrogenase, Specific Reagent For… 1
- LCD Enzyme Immunoassay, Gentamicin 1
- DIS Enzyme Immunoassay, Barbiturate 1
- KLT Enzyme Immunoassay, Carbamazepine 1
- LAR Enzyme Immunoassay, Procainamide 1
- KLB Radioimmunoassay, Tobramycin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K011920 | Emit 2000 Digoxin Assay, Model OSR4H229KXT · Special | 07/02/2001SE |
| K011620 | Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229LAN · Special | 06/18/2001SE |
| K011605 | Emit 2000 Quinidine Assay, Model OSR4Q229LBZ · Special | 06/12/2001SE |
| K011300 | Emit II Plus Cannabinoid Assay, Model OSR9N229LDJ · Special | 05/17/2001SE |
| K011306 | Emit II Plus Benzodiazepine Assay, Model 0SR9F229JXM · Special | 05/16/2001SE |
| K011289 | Emit II Plus Opiate Assay, Model OSR9B229DJG · Special | 05/15/2001SE |
| K011161 | Modification to the Emit II Plus Phencyclidine Assay, Model OSR9J229LCM · Special | 05/15/2001SE |
| K011166 | Modification to Emit 2000 Theophylline Assay, Model Osr 4P229KLS · Special | 05/10/2001SE |
| K011164 | Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229KXS · Special | 05/10/2001SE |
| K011163 | Modification to the Emit II Plus Propoxyphene Assay, Model OSR9G229JXN · Special | 05/10/2001SE |
| K011162 | Modification to the Emit II Plus Cocaine Metabolite AssayDIO · Special | 05/02/2001SE |
| K010962 | Emit II Plus Methadone Assay, Model OSRE229DJR · Special | 04/26/2001SE |
| K010960 | Emit II Plus Ethyl Alcohol Assay, Model OSR9K229DIC · Special | 04/26/2001SE |
| K010984 | Emit 2000 Gentamicin Plus AssayLCD · Special | 04/20/2001SE |
| K010934 | Emit II Plus Barbituate Assay, Model 0SR9D0229DIS · Special | 04/20/2001SE |
| K010814 | Emit 2000 Carbamazepine Assay, Model OSR4F229KLT · Special | 04/13/2001SE |
| K010812 | Emit 2000 Procainamide Assay, Model OSR4K229LAR · Special | 04/13/2001SE |
| K003341 | Emit 2000 Tobramycin Assay Emit 2000 Tobramycin CalibratorsKLB · Traditional | 01/22/2001SE |
| K000600 | Syva Emit 2000 Thyroxine Assay, CalibratorsKLI · Traditional | 03/27/2000SE |