OLYMPUS PK-TP ABSORBENT KIT

Antigens, Ha, Treponema Pallidum

FUJIREBIO AMERICA, INC.

The following data is part of a premarket notification filed by Fujirebio America, Inc. with the FDA for Olympus Pk-tp Absorbent Kit.

Pre-market Notification Details

Device IDK905038
510k NumberK905038
Device Name:OLYMPUS PK-TP ABSORBENT KIT
ClassificationAntigens, Ha, Treponema Pallidum
Applicant FUJIREBIO AMERICA, INC. 30 TWO BRIDGES RD. Fairfield,  NJ  07006
ContactRichard H Arnette
CorrespondentRichard H Arnette
FUJIREBIO AMERICA, INC. 30 TWO BRIDGES RD. Fairfield,  NJ  07006
Product CodeGMT  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-06
Decision Date1991-05-06

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