Cleared Traditional

ANTISERUM TO HUMAN APOLIPOPROTEIN A-I

K850691 · Kent Laboratories, Inc. · Immunology
Nov 1985
Decision
253d
Days
Class 1
Risk

About This 510(k) Submission

K850691 is an FDA 510(k) clearance for the ANTISERUM TO HUMAN APOLIPOPROTEIN A-I, a Apolipoproteins (Class I — General Controls, product code MSJ), submitted by Kent Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on November 1, 1985, 253 days after receiving the submission on February 21, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K850691 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1985
Decision Date November 01, 1985
Days to Decision 253 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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