K-ASSAY ALPHA-1 AG

Alpha-1-acid-glycoprotein, 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 Alpha-1 Ag.

Pre-market Notification Details

Device IDK993441
510k NumberK993441
Device Name:K-ASSAY ALPHA-1 AG
ClassificationAlpha-1-acid-glycoprotein, 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 CodeLKL  
CFR Regulation Number866.5420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-12
Decision Date1999-11-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816426020146 K993441 000

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