K994341 is an FDA 510(k) clearance for the FIBRINOGEN CALIBRATOR KIT. This device is classified as a Fibrinogen Standard (Class II - Special Controls, product code GFX).
Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on March 3, 2000, 71 days after receiving the submission on December 23, 1999.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7340.
| 510(k) Number | K994341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1999 |
| Decision Date | March 03, 2000 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GFX — Fibrinogen Standard |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7340 |