ELSA-HCT

Radioimmunoassay, Calcitonin

CIS-US, INC.

The following data is part of a premarket notification filed by Cis-us, Inc. with the FDA for Elsa-hct.

Pre-market Notification Details

Device IDK951708
510k NumberK951708
Device Name:ELSA-HCT
ClassificationRadioimmunoassay, Calcitonin
Applicant CIS-US, INC. 10 DE ANGELO DR. Bedford,  MA  01730
ContactMary E Donovan
CorrespondentMary E Donovan
CIS-US, INC. 10 DE ANGELO DR. Bedford,  MA  01730
Product CodeJKR  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number862.1140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-13
Decision Date1995-09-05

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