RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL

Radioimmunoassay, Cortisol

CAMBRIDGE MEDICAL TECHNOLOGY

The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for Radioimmunoassay Of No Spin(tm) Cortisol.

Pre-market Notification Details

Device IDK862871
510k NumberK862871
Device Name:RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL
ClassificationRadioimmunoassay, Cortisol
Applicant CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica,  MA  01865
ContactAnne M Kulis
CorrespondentAnne M Kulis
CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica,  MA  01865
Product CodeCGR  
CFR Regulation Number862.1205 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-29
Decision Date1986-08-19

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