IN-VITRO TBG RADIOIMMUNOASSAY TEST

Radioimmunoassay, Thyroxine-binding Globulin

CLINICAL ASSAYS, INC.

The following data is part of a premarket notification filed by Clinical Assays, Inc. with the FDA for In-vitro Tbg Radioimmunoassay Test.

Pre-market Notification Details

Device IDK810967
510k NumberK810967
Device Name:IN-VITRO TBG RADIOIMMUNOASSAY TEST
ClassificationRadioimmunoassay, Thyroxine-binding Globulin
Applicant CLINICAL ASSAYS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCEE  
CFR Regulation Number862.1685 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-08
Decision Date1981-04-23

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