T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT

Radioimmunoassay, Total Thyroxine

CAMBRIDGE MEDICAL TECHNOLOGY

The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for T4 No Spin(tm) Coated Tube Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK870573
510k NumberK870573
Device Name:T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Total Thyroxine
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 CodeCDX  
CFR Regulation Number862.1700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-02-10
Decision Date1987-04-22

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