NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY

Radioimmunoassay, Total Triiodothyronine

CAMBRIDGE MEDICAL TECHNOLOGY

The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for No Spin(tm) T3 Coated Tube Radioimmunoassay.

Pre-market Notification Details

Device IDK873737
510k NumberK873737
Device Name:NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY
ClassificationRadioimmunoassay, Total Triiodothyronine
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 CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-15
Decision Date1987-11-24

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