Cleared Traditional

K993441 - K-ASSAY ALPHA-1 AG
(FDA 510(k) Clearance)

K993441 · Kamiya Biomedical Co. · Immunology

Nov 1999

Decision

43d

Days

Class 1

Risk

K993441 is an FDA 510(k) clearance for the K-ASSAY ALPHA-1 AG, a Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (Class I — General Controls, product code LKL), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on November 24, 1999, 43 days after receiving the submission on October 12, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5420.

Submission Details

510(k) Number	K993441 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 12, 1999
Decision Date	November 24, 1999
Days to Decision	43 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement