VITAMIN B12/FOLATE DUAL RADIOASSAY KITS

Acid, Folic, Radioimmunoassay

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Vitamin B12/folate Dual Radioassay Kits.

Pre-market Notification Details

Device IDK812979
510k NumberK812979
Device Name:VITAMIN B12/FOLATE DUAL RADIOASSAY KITS
ClassificationAcid, Folic, Radioimmunoassay
Applicant AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCGN  
CFR Regulation Number862.1295 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-10-23
Decision Date1981-11-24

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