FLUROMETER, DADE

Fluorometer

DADE, BAXTER TRAVENOL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Dade, Baxter Travenol Diagnostics, Inc. with the FDA for Flurometer, Dade.

Pre-market Notification Details

Device IDK782150
510k NumberK782150
Device Name:FLUROMETER, DADE
ClassificationFluorometer
Applicant DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJZT  
CFR Regulation Number866.4520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-12-26
Decision Date1979-02-15

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