IMMPULSE T, ASSAY REAGENTS

Radioimmunoassay, Total Triiodothyronine

SCLAVO, INC.

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

Pre-market Notification Details

Device IDK881214
510k NumberK881214
Device Name:IMMPULSE T, ASSAY REAGENTS
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant SCLAVO, INC. 1240 ELKO DR. Sunnyvale,  CA  94089
ContactMichael Brinkley
CorrespondentMichael Brinkley
SCLAVO, INC. 1240 ELKO DR. Sunnyvale,  CA  94089
Product CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-21
Decision Date1988-05-27

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