API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC

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(r) Micro-mic(r) System/uniscept Mic.

Pre-market Notification Details

Device IDK874466
510k NumberK874466
Device Name:API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
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 Received1987-11-02
Decision Date1987-12-09

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