K884485 is an FDA 510(k) clearance for the KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT. This device is classified as a Activated Partial Thromboplastin (Class II - Special Controls, product code GFO).
Submitted by King Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 28, 1988, 64 days after receiving the submission on October 25, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7925.
| 510(k) Number | K884485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1988 |
| Decision Date | December 28, 1988 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GFO — Activated Partial Thromboplastin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7925 |