K894617 is an FDA 510(k) clearance for the OLYMPUS PK-TP SYSTEM REACTIVE CONTROL. This device is classified as a Antigen, Cf And / Or Id, Coccidioides Immitis (Class II - Special Controls, product code GMI).
Submitted by Schiff & Co. (West Cadwell, US). The FDA issued a Cleared decision on October 31, 1989, 103 days after receiving the submission on July 20, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3135.
| 510(k) Number | K894617 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1989 |
| Decision Date | October 31, 1989 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GMI — Antigen, Cf And / Or Id, Coccidioides Immitis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3135 |