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 |