K073367 is an FDA 510(k) clearance for the HEMOSIL FIBRINOGEN-C. This device is classified as a System, Fibrinogen Determination (Class II - Special Controls, product code KQJ).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on December 27, 2007, 27 days after receiving the submission on November 30, 2007.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7340.
| 510(k) Number | K073367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2007 |
| Decision Date | December 27, 2007 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | KQJ — System, Fibrinogen Determination |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7340 |