GAMMADAB (125 1) FOLATE RADIOASSAY KIT

Acid, Folic, Radioimmunoassay

CLINICAL ASSAYS, INC.

The following data is part of a premarket notification filed by Clinical Assays, Inc. with the FDA for Gammadab (125 1) Folate Radioassay Kit.

Pre-market Notification Details

Device IDK791079
510k NumberK791079
Device Name:GAMMADAB (125 1) FOLATE RADIOASSAY KIT
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 Received1979-06-12
Decision Date1979-07-17

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