QUAD FERM +

Kit, Identification, Neisseria Gonorrhoeae

ANALYTICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Quad Ferm +.

Pre-market Notification Details

Device IDK853544
510k NumberK853544
Device Name:QUAD FERM +
ClassificationKit, Identification, Neisseria Gonorrhoeae
Applicant ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview ,  NY  11803 -
ContactSusan D Tiedy
CorrespondentSusan D Tiedy
ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview ,  NY  11803 -
Product CodeJSX  
CFR Regulation Number866.2660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-08-26
Decision Date1985-09-05

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