K934351 is an FDA 510(k) clearance for the APTT-ES REAGENT. This device is classified as a Activated Partial Thromboplastin (Class II - Special Controls, product code GFO).
Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on December 6, 1993, 90 days after receiving the submission on September 7, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7925.
| 510(k) Number | K934351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 1993 |
| Decision Date | December 06, 1993 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GFO — Activated Partial Thromboplastin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7925 |