Cleared Traditional

K-ASSAY C4

K993481 · Kamiya Biomedical Co. · Immunology
Nov 1999
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K993481 is an FDA 510(k) clearance for the K-ASSAY C4, a Complement C4, Antigen, Antiserum, Control (Class II — Special Controls, product code DBI), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on November 29, 1999, 46 days after receiving the submission on October 14, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K993481 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1999
Decision Date November 29, 1999
Days to Decision 46 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DBI — Complement C4, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240