Company ยท US
Syva Co., Dade Behring, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2001. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 1 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 |
| JXN | Enzyme Immunoassay, Propoxyphene | 1 |
| KLB | Radioimmunoassay, Tobramycin | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 |
| KLS | Enzyme Immunoassay, Theophylline | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 |
| KXS | Radioimmunoassay, Methaqualone | 1 |
| KXT | Enzyme Immunoassay, Digoxin | 1 |
| LAN | Enzyme Immunoassay, N-Acetylprocainamide | 1 |
| LAR | Enzyme Immunoassay, Procainamide | 1 |
| LBZ | Enzyme Immunoassay, Quinidine | 1 |
| LCD | Enzyme Immunoassay, Gentamicin | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 2, 2001 | K011920 | EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 Syva Co., Dade Behring, Inc. | KXT |
| Jun 18, 2001 | K011620 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 Syva Co., Dade Behring, Inc. | LAN |
| Jun 12, 2001 | K011605 | EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 Syva Co., Dade Behring, Inc. | LBZ |
| May 17, 2001 | K011300 | EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 Syva Co., Dade Behring, Inc. | LDJ |
| May 16, 2001 | K011306 | EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 Syva Co., Dade Behring, Inc. | JXM |
| May 15, 2001 | K011289 | EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 Syva Co., Dade Behring, Inc. | DJG |
| May 15, 2001 | K011161 | MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 Syva Co., Dade Behring, Inc. | LCM |
| May 10, 2001 | K011166 | MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 Syva Co., Dade Behring, Inc. | KLS |
| May 10, 2001 | K011164 | MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 Syva Co., Dade Behring, Inc. | KXS |
| May 10, 2001 | K011163 | MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 Syva Co., Dade Behring, Inc. | JXN |
| May 2, 2001 | K011162 | MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY Syva Co., Dade Behring, Inc. | DIO |
| Apr 26, 2001 | K010962 | EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 Syva Co., Dade Behring, Inc. | DJR |
| Apr 26, 2001 | K010960 | EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 Syva Co., Dade Behring, Inc. | DIC |
| Apr 20, 2001 | K010984 | EMIT 2000 GENTAMICIN PLUS ASSAY Syva Co., Dade Behring, Inc. | LCD |
| Apr 20, 2001 | K010934 | EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 Syva Co., Dade Behring, Inc. | DIS |
| Apr 13, 2001 | K010814 | EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 Syva Co., Dade Behring, Inc. | KLT |
| Apr 13, 2001 | K010812 | EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 Syva Co., Dade Behring, Inc. | LAR |
| Jan 22, 2001 | K003341 | EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS Syva Co., Dade Behring, Inc. | KLB |
| Mar 27, 2000 | K000600 | SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS Syva Co., Dade Behring, Inc. | KLI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||