K905038 is an FDA 510(k) clearance for the OLYMPUS PK-TP ABSORBENT KIT. This device is classified as a Antigens, Ha, Treponema Pallidum (Class II - Special Controls, product code GMT).
Submitted by Fujirebio America, Inc. (Fairfield, US). The FDA issued a Cleared decision on May 6, 1991, 181 days after receiving the submission on November 6, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K905038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 1990 |
| Decision Date | May 06, 1991 |
| Days to Decision | 181 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 |