RIA-GNOST PROGESTERONE

Radioimmunoassay, Progesterone

CAMBRIDGE MEDICAL TECHNOLOGY

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

Pre-market Notification Details

Device IDK890836
510k NumberK890836
Device Name:RIA-GNOST PROGESTERONE
ClassificationRadioimmunoassay, Progesterone
Applicant CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica,  MA  01865
ContactM Krawczyk
CorrespondentM Krawczyk
CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica,  MA  01865
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-21
Decision Date1989-03-16

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