K022195 is an FDA 510(k) clearance for the COAMATIC AT-400. This device is classified as a Antithrombin Iii Quantitation (Class II - Special Controls, product code JBQ).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on August 7, 2002, 33 days after receiving the submission on July 5, 2002.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7060.
| 510(k) Number | K022195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2002 |
| Decision Date | August 07, 2002 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JBQ — Antithrombin Iii Quantitation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7060 |