Cleared Traditional

K-ASSAY HAPTOGLOBIN

K993480 · Kamiya Biomedical Co. · Immunology
Nov 1999
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K993480 is an FDA 510(k) clearance for the K-ASSAY HAPTOGLOBIN, a Haptoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DAD), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on November 24, 1999, 41 days after receiving the submission on October 14, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5460.

Submission Details

510(k) Number K993480 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1999
Decision Date November 24, 1999
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DAD — Haptoglobin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5460

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