K023362 is an FDA 510(k) clearance for the FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN. This device is classified as a Instrument, Coagulation, Automated (Class II - Special Controls, product code GKP).
Submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on December 9, 2002, 63 days after receiving the submission on October 7, 2002.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5400.
| 510(k) Number | K023362 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2002 |
| Decision Date | December 09, 2002 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKP — Instrument, Coagulation, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5400 |