K-ASSAY C3

Complement C3, Antigen, Antiserum, Control

KAMIYA BIOMEDICAL CO.

The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay C3.

Pre-market Notification Details

Device IDK993437
510k NumberK993437
Device Name:K-ASSAY C3
ClassificationComplement C3, Antigen, Antiserum, Control
Applicant KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle,  WA  98188 -3412
ContactColin Getty
CorrespondentColin Getty
KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. Seattle,  WA  98188 -3412
Product CodeCZW  
CFR Regulation Number866.5240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-12
Decision Date1999-11-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816426020078 K993437 000

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