PARATHYROID HORMONE RADIOIMMUNOASSAY KIT

Radioimmunoassay, Parathyroid Hormone

CAMBRIDGE MEDICAL TECHNOLOGY

The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for Parathyroid Hormone Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK850254
510k NumberK850254
Device Name:PARATHYROID HORMONE RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Parathyroid Hormone
Applicant CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica,  MA  01865
ContactCarole Varanelli
CorrespondentCarole Varanelli
CAMBRIDGE MEDICAL TECHNOLOGY 575 MIDDLESEX TURNPIKE Billerica,  MA  01865
Product CodeCEW  
CFR Regulation Number862.1545 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-01-22
Decision Date1985-04-03

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