ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST

Antigens, Cf (including Cf Control), Adenovirus 1-33

CAMBRIDGE BIOSCIENCE CORP.

The following data is part of a premarket notification filed by Cambridge Bioscience Corp. with the FDA for Adenoclone(tm)-ifa, Adenovirus Antigen Test.

Pre-market Notification Details

Device IDK873312
510k NumberK873312
Device Name:ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST
ClassificationAntigens, Cf (including Cf Control), Adenovirus 1-33
Applicant CAMBRIDGE BIOSCIENCE CORP. 365 PLANTATION ST. Worcester,  MA  01605
ContactJack Cassorla
CorrespondentJack Cassorla
CAMBRIDGE BIOSCIENCE CORP. 365 PLANTATION ST. Worcester,  MA  01605
Product CodeGOD  
CFR Regulation Number866.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-18
Decision Date1988-02-24

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