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 |