Cleared Traditional

QM300 CERULOPLASMIN ANTIBODY PACK

K895377 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology
Sep 1989
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K895377 is an FDA 510(k) clearance for the QM300 CERULOPLASMIN ANTIBODY PACK, a Ceruloplasmin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDB), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on September 21, 1989, 22 days after receiving the submission on August 30, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5210.

Submission Details

510(k) Number K895377 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1989
Decision Date September 21, 1989
Days to Decision 22 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DDB — Ceruloplasmin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5210

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