Cleared Traditional

K861883 - IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1
(FDA 510(k) Clearance)

K861883 · Orion Corp. · Immunology
Oct 1986
Decision
167d
Days
Class 1
Risk

K861883 is an FDA 510(k) clearance for the IMMUNOCHEMICAL ASSAY OF APOLIPOPROTEIN A1, a Apolipoproteins (Class I — General Controls, product code MSJ), submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on October 29, 1986, 167 days after receiving the submission on May 15, 1986. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K861883 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1986
Decision Date October 29, 1986
Days to Decision 167 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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