REAGENTS FOR TSH ASSAY

Radioimmunoassay, Thyroid-stimulating Hormone

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Reagents For Tsh Assay.

Pre-market Notification Details

Device IDK881381
510k NumberK881381
Device Name:REAGENTS FOR TSH ASSAY
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant SCLAVO, INC. 1240 ELKO DR. Sunnyvale,  CA  94089
ContactMichael Brinkley
CorrespondentMichael Brinkley
SCLAVO, INC. 1240 ELKO DR. Sunnyvale,  CA  94089
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-01
Decision Date1988-07-21

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