K881999 is an FDA 510(k) clearance for the PLATELIN(R) EXCEL L. This device is classified as a Reagent & Control, Partial Thromboplastin Time (Class II - Special Controls, product code GIT).
Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on August 17, 1988, 97 days after receiving the submission on May 12, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7925.
| 510(k) Number | K881999 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 1988 |
| Decision Date | August 17, 1988 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GIT — Reagent & Control, Partial Thromboplastin Time |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7925 |