Cleared Traditional

K-ASSAY ALPHA-1 AT

K993444 · Kamiya Biomedical Co. · Immunology
Nov 1999
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K993444 is an FDA 510(k) clearance for the K-ASSAY ALPHA-1 AT, a Alpha-1-antitrypsin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEM), 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 866.5130.

Submission Details

510(k) Number K993444 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

Device Classification

Product Code DEM — Alpha-1-antitrypsin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5130

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