Cleared Traditional

K862671 - MICROALBUMINURIA ASSAY
(FDA 510(k) Clearance)

K862671 · Orion Corp. · Immunology

Sep 1986

Decision

66d

Days

Class 2

Risk

K862671 is an FDA 510(k) clearance for the MICROALBUMINURIA ASSAY, a Albumin, Antigen, Antiserum, Control (Class II — Special Controls, product code DCF), submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on September 18, 1986, 66 days after receiving the submission on July 14, 1986. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number	K862671 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 1986
Decision Date	September 18, 1986
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—