TEST, RIA, TRIODOTHYRONINE

Radioimmunoassay, Total Triiodothyronine

SMITH KLINE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Test, Ria, Triodothyronine.

Pre-market Notification Details

Device IDK760057
510k NumberK760057
Device Name:TEST, RIA, TRIODOTHYRONINE
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1976-06-16
Decision Date1976-09-13

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