Baxter Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 72
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K934458 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | July 18, 1995 |
| K950817 | DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI | April 25, 1995 |
| K935704 | DRIED GRAM-NEGATIVE MIC//COMBO PANELS | April 14, 1995 |
| K950570 | STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY | April 11, 1995 |
| K945235 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | March 7, 1995 |
| K941030 | DRIED GRAM-NEGATIVE CEFPODOXIME | February 16, 1995 |
| K940917 | LORACARBEF GRAM-NAGATIVE PANELS | February 8, 1995 |
| K941459 | GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX | February 3, 1995 |
| K941317 | DRIED GRAM NEGATIVE/CEFMETAZOLE | January 31, 1995 |
| K942089 | MICRODILUTION/LORACARBEF PANELS | January 9, 1995 |
| K942267 | DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE | January 9, 1995 |
| K943510 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | December 2, 1994 |
| K935307 | DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA | November 22, 1994 |
| K934003 | STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY | November 22, 1994 |
| K935702 | DADE INNOVIN II | November 22, 1994 |
| K933414 | STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY | November 22, 1994 |
| K944651 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | November 18, 1994 |
| K934323 | DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL | October 19, 1994 |
| K935987 | FLEXTRANS | August 15, 1994 |
| K936196 | ANTITHROMBIN III CHROMOGENIC ASSAY | May 4, 1994 |