CHLAMYDIA FLUORO-KIT 1680

Antiserum, Fluorescent, Chlamydia Trachomatis

CLINICAL SCIENCES, INC.

The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Chlamydia Fluoro-kit 1680.

Pre-market Notification Details

Device IDK850158
510k NumberK850158
Device Name:CHLAMYDIA FLUORO-KIT 1680
ClassificationAntiserum, Fluorescent, Chlamydia Trachomatis
Applicant CLINICAL SCIENCES, INC. 30 TROY RD. Whippany,  NJ  07981
ContactMarylou Panico
CorrespondentMarylou Panico
CLINICAL SCIENCES, INC. 30 TROY RD. Whippany,  NJ  07981
Product CodeLJP  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-15
Decision Date1985-03-21

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