ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)

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(r)-type 40/41 Eia Diagnostic Test (48).

Pre-market Notification Details

Device IDK881894
510k NumberK881894
Device Name:ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)
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 Received1988-05-05
Decision Date1988-07-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840733101748 K881894 000

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