K932145 is an FDA 510(k) clearance for the COAGULATION REFERENCE PLASMA, NORMAL. This device is classified as a Plasma, Control, Normal (Class II - Special Controls, product code GIZ).
Submitted by American Diagnostic Corp. (Greenwich, US). The FDA issued a Cleared decision on October 18, 1993, 167 days after receiving the submission on May 4, 1993.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K932145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1993 |
| Decision Date | October 18, 1993 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GIZ — Plasma, Control, Normal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |