I-Stat Corporation
I-Stat Corporation appears in FDA public data with 0 recalls, 7 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on July 21, 2006.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K053597 | I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) | July 21, 2006 |
| K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT E | January 13, 2006 |
| K051433 | I-STAT CREATINE KINASE MB (CK-MB) | December 15, 2005 |
| K031873 | I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL S | October 7, 2003 |
| K023582 | I-STAT KAOLIN ACT TEST | September 8, 2003 |
| K031739 | I-STAT CARDIAC TROPONIN (CTNI) TEST | September 2, 2003 |
| K020355 | I-STAT PROTHROMBIN TIME TEST | May 14, 2002 |