AUTOBEAD THYROID UPTAKE

Fluorometer, For Clinical Use

BIO-CHEM LABORATORY SYSTEMS, INC.

The following data is part of a premarket notification filed by Bio-chem Laboratory Systems, Inc. with the FDA for Autobead Thyroid Uptake.

Pre-market Notification Details

Device IDK930689
510k NumberK930689
Device Name:AUTOBEAD THYROID UPTAKE
ClassificationFluorometer, For Clinical Use
Applicant BIO-CHEM LABORATORY SYSTEMS, INC. 195 LEHIGH AVE. Lakewood,  NJ  08701
ContactJon D Turpen
CorrespondentJon D Turpen
BIO-CHEM LABORATORY SYSTEMS, INC. 195 LEHIGH AVE. Lakewood,  NJ  08701
Product CodeKHO  
CFR Regulation Number862.2560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-10
Decision Date1993-11-10

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