RIA-GNOST INSULIN

Radioimmunoassay, Immunoreactive Insulin

CAMBRIDGE MEDICAL TECHNOLOGY

The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for Ria-gnost Insulin.

Pre-market Notification Details

Device IDK890837
510k NumberK890837
Device Name:RIA-GNOST INSULIN
ClassificationRadioimmunoassay, Immunoreactive Insulin
Applicant CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica,  MA  01865
ContactM Krawczyk
CorrespondentM Krawczyk
CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica,  MA  01865
Product CodeCFP  
CFR Regulation Number862.1405 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-21
Decision Date1989-04-26

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