K922416 is an FDA 510(k) clearance for the FIBRINOGEN RID TEST KIT. This device is classified as a System, Fibrinogen Determination (Class II - Special Controls, product code KQJ).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on March 9, 1993, 292 days after receiving the submission on May 21, 1992.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7340.
| 510(k) Number | K922416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1992 |
| Decision Date | March 09, 1993 |
| Days to Decision | 292 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | KQJ — System, Fibrinogen Determination |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7340 |