K923921 is an FDA 510(k) clearance for the IL TEST PT FIBRINOGEN HS. This device is classified as a Test, Fibrinogen (Class II - Special Controls, product code GIS).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 26, 1992, 82 days after receiving the submission on August 5, 1992.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7340.
| 510(k) Number | K923921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1992 |
| Decision Date | October 26, 1992 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GIS — Test, Fibrinogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7340 |