THE FIAX 5000 FLUOROMETER

Fluorometer

WHITTAKER BIOPRODUCTS, INC.

The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for The Fiax 5000 Fluorometer.

Pre-market Notification Details

Device IDK863434
510k NumberK863434
Device Name:THE FIAX 5000 FLUOROMETER
ClassificationFluorometer
Applicant WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
ContactPatricia B Shrader
CorrespondentPatricia B Shrader
WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
Product CodeJZT  
CFR Regulation Number866.4520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-04
Decision Date1986-10-29

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