The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Olympus Pk(tm) Tp.
| Device ID | K893124 |
| 510k Number | K893124 |
| Device Name: | OLYMPUS PK(TM) TP |
| Classification | Antigens, Ha, Treponema Pallidum |
| Applicant | FUJIREBIO DIAGNOSTICS, INC. SCHIFF & COMPANY 583 MOUNTAIN AVENUE North Caldwell, NJ 07006 |
| Contact | Jane B Campbell |
| Correspondent | Jane B Campbell FUJIREBIO DIAGNOSTICS, INC. SCHIFF & COMPANY 583 MOUNTAIN AVENUE North Caldwell, 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 | 1989-04-25 |
| Decision Date | 1989-11-17 |