Syva Co., Dade Behring, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 19
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K011920 | EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 | July 2, 2001 |
| K011620 | EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229 | June 18, 2001 |
| K011605 | EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 | June 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 |
| K011163 | MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 | May 10, 2001 |
| K011164 | MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 | May 10, 2001 |
| K011166 | MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 | May 10, 2001 |
| K011162 | MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY | May 2, 2001 |
| K010962 | EMIT II PLUS METHADONE ASSAY, MODEL OSRE229 | April 26, 2001 |
| K010960 | EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229 | April 26, 2001 |
| K010984 | EMIT 2000 GENTAMICIN PLUS ASSAY | April 20, 2001 |
| K010934 | EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229 | April 20, 2001 |
| K010814 | EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 | April 13, 2001 |
| K010812 | EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 | April 13, 2001 |
| K003341 | EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS | January 22, 2001 |
| K000600 | SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS | March 27, 2000 |