K951072 is an FDA 510(k) clearance for the PROTIME MICROCOAGULATION SYSTEM. This device is classified as a Instrument, Coagulation, Automated (Class II — Special Controls, product code GKP).
Submitted by International Technidyne Corp. (Edison, US). The FDA issued a Cleared decision on October 27, 1995, 233 days after receiving the submission on March 8, 1995.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5400.
| 510(k) Number | K951072 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1995 |
| Decision Date | October 27, 1995 |
| Days to Decision | 233 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GKP — Instrument, Coagulation, Automated |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5400 |