API UNISCEPT KB

Manual Antimicrobial Susceptibility Test Systems

ANALYTICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Analytical Products, Inc. with the FDA for Api Uniscept Kb.

Pre-market Notification Details

Device IDK895796
510k NumberK895796
Device Name:API UNISCEPT KB
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview ,  NY  11803 -
ContactValerie L Vargo
CorrespondentValerie L Vargo
ANALYTICAL PRODUCTS, INC. 200 EXPRESS STREET Plainview ,  NY  11803 -
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-28
Decision Date1989-11-13

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