Crestat Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 29
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K980883 | N-ASSAY GLU-UL | September 3, 1998 |
| K981276 | N-ASSAY L D-BIL | May 1, 1998 |
| K981289 | N-ASSAY L T-BIL | April 27, 1998 |
| K980902 | N-ASSAY L AST/GOT | March 26, 1998 |
| K980900 | N-ASSAY CPK-L | March 26, 1998 |
| K971985 | N-ASSAY TIA PLASMINOGEN TEST KIT | October 20, 1997 |
| K972257 | N-ASSAY TIA ANTITHROMBIN III TEST KIT | October 20, 1997 |
| K964296 | N-ASSAY TIA APO B TEST KIT | August 1, 1997 |
| K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | August 1, 1997 |
| K964292 | N-ASSAY TIA APO A1 TEST KIT | August 1, 1997 |
| K964297 | N-ASSAY TIA C4 TEST KIT | July 14, 1997 |
| K964298 | N-ASSAY TIA MULTI V-NL | July 14, 1997 |
| K965100 | N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT | July 14, 1997 |
| K965024 | N-ASSAY TIA C1-INACTIVATOR TEST KIT | July 14, 1997 |
| K964300 | N-ASSAY TIA MULTI V-NL | July 14, 1997 |
| K964301 | N-ASSAY TIA MULTI V-NL | July 14, 1997 |
| K964299 | N-ASSAY TIA MULTI V-NL | July 14, 1997 |
| K965110 | N-ASSAY TIA MULTI CRP CALIBRATOR SET | July 3, 1997 |
| K964295 | N-ASSAY TIA TRANSFERRIN TEST KIT | June 16, 1997 |
| K965113 | N-ASSAY TIA FIBRINOGEN TEST KIT | April 16, 1997 |