K924892 is an FDA 510(k) clearance for the FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM. This device is classified as a Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control (Class II - Special Controls, product code DAT).
Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on April 21, 1994, 569 days after receiving the submission on September 29, 1992.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7340.
| 510(k) Number | K924892 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 1992 |
| Decision Date | April 21, 1994 |
| Days to Decision | 569 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | DAT — Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7340 |