FLUORESCENCE CONCENTRATION ANALYZER (FCA)

Fluorometer

PANDEX LABORATORIES, INC.

The following data is part of a premarket notification filed by Pandex Laboratories, Inc. with the FDA for Fluorescence Concentration Analyzer (fca).

Pre-market Notification Details

Device IDK864699
510k NumberK864699
Device Name:FLUORESCENCE CONCENTRATION ANALYZER (FCA)
ClassificationFluorometer
Applicant PANDEX LABORATORIES, INC. 909 ORCHARD ST. Mundelein,  IL  60060
ContactHank Juske
CorrespondentHank Juske
PANDEX LABORATORIES, INC. 909 ORCHARD ST. Mundelein,  IL  60060
Product CodeJZT  
CFR Regulation Number866.4520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-02
Decision Date1986-12-22

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