FIAX C4 ASSAY

Complement C1q, Antigen, Antiserum, Control

IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS

The following data is part of a premarket notification filed by Idt, A Division Of Whittaker M.a. Bioproducts with the FDA for Fiax C4 Assay.

Pre-market Notification Details

Device IDK772114
510k NumberK772114
Device Name:FIAX C4 ASSAY
ClassificationComplement C1q, Antigen, Antiserum, Control
Applicant IDT, A DIVISION OF WHITTAKER M.A. BIOPRODUCTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDAK  
CFR Regulation Number866.5240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-11-07
Decision Date1977-11-30

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