ECLIPSE ICA TSH

Radioimmunoassay, Thyroid-stimulating Hormone

BIOTOPE, INC.

The following data is part of a premarket notification filed by Biotope, Inc. with the FDA for Eclipse Ica Tsh.

Pre-market Notification Details

Device IDK910256
510k NumberK910256
Device Name:ECLIPSE ICA TSH
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant BIOTOPE, INC. 12277 134TH CT., N.E. Redmond,  WA  98052
ContactLynn Shanta
CorrespondentLynn Shanta
BIOTOPE, INC. 12277 134TH CT., N.E. Redmond,  WA  98052
Product CodeJLW  
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-22
Decision Date1991-02-22

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