BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

BIOCHECK, INC.

The following data is part of a premarket notification filed by Biocheck, Inc. with the FDA for Biocheck Total T4 Enzyme Immunoassay Test Kit, Model Bc-1007.

Pre-market Notification Details

Device IDK991432
510k NumberK991432
Device Name:BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
ClassificationEnzyme Immunoassay, Non-radiolabeled, Total Thyroxine
Applicant BIOCHECK, INC. 9418 LASAINE AVE. Northridge,  CA  91325
ContactRobin J Hellen
CorrespondentRobin J Hellen
BIOCHECK, INC. 9418 LASAINE AVE. Northridge,  CA  91325
Product CodeKLI  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-26
Decision Date1999-06-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00811727013149 K991432 000
B24225TT4HUE010 K991432 000
00840239017819 K991432 000
00850392007077 K991432 000
04048474017816 K991432 000

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