K081769 is an FDA 510(k) clearance for the INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5. This device is classified as a Antithrombin Iii Quantitation (Class II - Special Controls, product code JBQ).
Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on May 28, 2009, 339 days after receiving the submission on June 23, 2008.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7060.
| 510(k) Number | K081769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2008 |
| Decision Date | May 28, 2009 |
| Days to Decision | 339 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 |