FOLATE RADIOASSAY KIT CA-1562-125

Acid, Folic, Radioimmunoassay

CLINICAL ASSAYS, INC.

The following data is part of a premarket notification filed by Clinical Assays, Inc. with the FDA for Folate Radioassay Kit Ca-1562-125.

Pre-market Notification Details

Device IDK832712
510k NumberK832712
Device Name:FOLATE RADIOASSAY KIT CA-1562-125
ClassificationAcid, Folic, Radioimmunoassay
Applicant CLINICAL ASSAYS, INC. 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 Received1983-08-12
Decision Date1983-10-04

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