Cleared Traditional

K861882 - IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B
(FDA 510(k) Clearance)

K861882 · Orion Corp. · Immunology

Oct 1986

Decision

167d

Days

Class 1

Risk

K861882 is an FDA 510(k) clearance for the IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B. This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K861882 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	—