FLUOROSKAN

Fluorometer

FLOW LABORATORIES, INC.

The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Fluoroskan.

Pre-market Notification Details

Device IDK842049
510k NumberK842049
Device Name:FLUOROSKAN
ClassificationFluorometer
Applicant FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean,  VA  22102
ContactGerald A Hahn
CorrespondentGerald A Hahn
FLOW LABORATORIES, INC. 7655 OLD SPRINGHOUSE RD. Mclean,  VA  22102
Product CodeJZT  
CFR Regulation Number866.4520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-22
Decision Date1984-12-03

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