Cleared Traditional

K-ASSAY C1-INA

K011780 · Kamiya Biomedical Co. · Immunology

Jul 2001

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K011780 is an FDA 510(k) clearance for the K-ASSAY C1-INA, a Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (Class II — Special Controls, product code DBA), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on July 25, 2001, 48 days after receiving the submission on June 7, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5250.

Submission Details

510(k) Number	K011780 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 2001
Decision Date	July 25, 2001
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DBA — Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5250