K893124 is an FDA 510(k) clearance for the OLYMPUS PK(TM) TP. This device is classified as a Antigens, Ha, Treponema Pallidum (Class II - Special Controls, product code GMT).
Submitted by Fujirebio Diagnostics,Inc. (North Caldwell, US). The FDA issued a Cleared decision on November 17, 1989, 206 days after receiving the submission on April 25, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K893124 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 1989 |
| Decision Date | November 17, 1989 |
| Days to Decision | 206 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GMT — Antigens, Ha, Treponema Pallidum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |