CORNING IMMUNOFIXATION SYS

Iga, Antigen, Antiserum, Control

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Immunofixation Sys.

Pre-market Notification Details

Device IDK843614
510k NumberK843614
Device Name:CORNING IMMUNOFIXATION SYS
ClassificationIga, Antigen, Antiserum, Control
Applicant CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCZP  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-14
Decision Date1984-10-05

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