Cleared Traditional

K884074 - IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G
(FDA 510(k) Clearance)

K884074 · Orion Diagnostica, Inc. · Immunology

Oct 1988

Decision

30d

Days

Class 2

Risk

K884074 is an FDA 510(k) clearance for the IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G. This device is classified as a Gamma Globulin, Antigen, Antiserum, Control (Class II — Special Controls, product code DAH).

Submitted by Orion Diagnostica, Inc. (02101 Espoo, FI). The FDA issued a Cleared decision on October 27, 1988, 30 days after receiving the submission on September 27, 1988.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K884074 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 1988
Decision Date	October 27, 1988
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—