VITAMIN B12 (57CO) RADIOIMMUNOASSAY

Radioassay, Vitamin B12

CORNING MEDICAL & SCIENTIFIC

The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Vitamin B12 (57co) Radioimmunoassay.

Pre-market Notification Details

Device IDK802220
510k NumberK802220
Device Name:VITAMIN B12 (57CO) RADIOIMMUNOASSAY
ClassificationRadioassay, Vitamin B12
Applicant CORNING MEDICAL & SCIENTIFIC 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCDD  
CFR Regulation Number862.1810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-09-12
Decision Date1981-01-09

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