OLYMPUS PK(TM) TP

Antigens, Ha, Treponema Pallidum

FUJIREBIO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Olympus Pk(tm) Tp.

Pre-market Notification Details

Device IDK893124
510k NumberK893124
Device Name:OLYMPUS PK(TM) TP
ClassificationAntigens, Ha, Treponema Pallidum
Applicant FUJIREBIO DIAGNOSTICS, INC. SCHIFF & COMPANY 583 MOUNTAIN AVENUE North Caldwell,  NJ  07006
ContactJane B Campbell
CorrespondentJane B Campbell
FUJIREBIO DIAGNOSTICS, INC. SCHIFF & COMPANY 583 MOUNTAIN AVENUE North Caldwell,  NJ  07006
Product CodeGMT  
CFR Regulation Number866.3830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-25
Decision Date1989-11-17

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