K883640 is an FDA 510(k) clearance for the KD ONE-STAGE PROTHROMBIN TIME TEST. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II - Special Controls, product code JPA).
Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 31, 1988, 67 days after receiving the submission on August 25, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K883640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1988 |
| Decision Date | October 31, 1988 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JPA — System, Multipurpose For In Vitro Coagulation Studies |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |