ENDAB TSH

Radioimmunoassay, Thyroid-stimulating Hormone

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Endab Tsh.

Pre-market Notification Details

Device IDK851980
510k NumberK851980
Device Name:ENDAB TSH
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston,  MA  02134
ContactJohn H Carter
CorrespondentJohn H Carter
IMMUNOTECH CORP. 90 WINDOM STREET, PO BOX 860 Boston,  MA  02134
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-05-07
Decision Date1985-05-31

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