ROTACLONE ROTAVIRUS DIAGNOSTIC KIT

Enzyme Linked Immunoabsorbent Assay, Rotavirus

CAMBRIDGE BIOSCIENCE CORP.

The following data is part of a premarket notification filed by Cambridge Bioscience Corp. with the FDA for Rotaclone Rotavirus Diagnostic Kit.

Pre-market Notification Details

Device IDK852969
510k NumberK852969
Device Name:ROTACLONE ROTAVIRUS DIAGNOSTIC KIT
ClassificationEnzyme Linked Immunoabsorbent Assay, Rotavirus
Applicant CAMBRIDGE BIOSCIENCE CORP. 35 SOUTH ST. Hopkinton,  MA  01748
ContactRod N Raynovich
CorrespondentRod N Raynovich
CAMBRIDGE BIOSCIENCE CORP. 35 SOUTH ST. Hopkinton,  MA  01748
Product CodeLIQ  
CFR Regulation Number866.3405 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-15
Decision Date1985-11-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840733101700 K852969 000

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