CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS

Antiserum, Fluorescent, Chlamydia Trachomatis

AMERICAN MICRO SCAN

The following data is part of a premarket notification filed by American Micro Scan with the FDA for Chlamydiae Fluor. Ab Test For Detection In Smears.

Pre-market Notification Details

Device IDK864662
510k NumberK864662
Device Name:CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS
ClassificationAntiserum, Fluorescent, Chlamydia Trachomatis
Applicant AMERICAN MICRO SCAN 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactJames E Keller
CorrespondentJames E Keller
AMERICAN MICRO SCAN 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
Product CodeLJP  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-28
Decision Date1987-03-25

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