THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST

Radioimmunoassay, Thyroid-stimulating Hormone

TECO DIAGNOSTICS

The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Thyroid Stiumlating Hormone (tsh-beads Assay) Test.

Pre-market Notification Details

Device IDK961629
510k NumberK961629
Device Name:THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant TECO DIAGNOSTICS 911 VIA RODEO Placentia,  CA  92670
ContactK C Chen
CorrespondentK C Chen
TECO DIAGNOSTICS 911 VIA RODEO Placentia,  CA  92670
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-26
Decision Date1996-09-11

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