The following data is part of a premarket notification filed by Fujirebio America, Inc. with the FDA for Olympus Pk-tp Absorbent Kit.
| Device ID | K905038 |
| 510k Number | K905038 |
| Device Name: | OLYMPUS PK-TP ABSORBENT KIT |
| Classification | Antigens, Ha, Treponema Pallidum |
| Applicant | FUJIREBIO AMERICA, INC. 30 TWO BRIDGES RD. Fairfield, NJ 07006 |
| Contact | Richard H Arnette |
| Correspondent | Richard H Arnette FUJIREBIO AMERICA, INC. 30 TWO BRIDGES RD. Fairfield, NJ 07006 |
| Product Code | GMT |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-06 |
| Decision Date | 1991-05-06 |