K931721 is an FDA 510(k) clearance for the IL TEST FIBRINOGEN-C. This device is classified as a System, Fibrinogen Determination (Class II - Special Controls, product code KQJ).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on August 13, 1993, 128 days after receiving the submission on April 7, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7340.
| 510(k) Number | K931721 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1993 |
| Decision Date | August 13, 1993 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| 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 |