Bayer Diagnostics Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 32
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K033379 | BAYER SPECIAL CHEMISTRY CONTROLS | December 19, 2003 |
| K033380 | BAYER SPECIAL CHEMISTRY CALIBRATORS | December 16, 2003 |
| K033007 | BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM | November 14, 2003 |
| K031857 | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY | September 4, 2003 |
| K022096 | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | March 18, 2003 |
| K030452 | BAYER LIGAND PLUS 1, 2, 3 CONTROLS | March 3, 2003 |
| K023840 | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | January 7, 2003 |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | December 24, 2002 |
| K022177 | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | December 17, 2002 |
| K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | November 27, 2002 |
| K023184 | ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | November 18, 2002 |
| K022178 | CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | November 12, 2002 |
| K022668 | ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD | October 15, 2002 |
| K020807 | AFP ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | October 1, 2002 |
| K022968 | ADVIA TESTPOINT CSF CONTROL | September 24, 2002 |
| K022331 | ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD | September 11, 2002 |
| K020616 | BAYER RAPIDPOINT 405 SYSTEM | July 17, 2002 |
| K021151 | AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | July 13, 2002 |
| K020794 | SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | July 11, 2002 |
| K020792 | ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | July 11, 2002 |