Cleared Traditional

QM300 APOLIPOPROTEIN B ANTIBODY PACK

K883714 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology
Oct 1988
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K883714 is an FDA 510(k) clearance for the QM300 APOLIPOPROTEIN B ANTIBODY PACK, a Apolipoproteins (Class I — General Controls, product code MSJ), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on October 19, 1988, 50 days after receiving the submission on August 30, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K883714 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1988
Decision Date October 19, 1988
Days to Decision 50 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code MSJ — Apolipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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