Cleared Traditional

K990552 - IMMUNOGLOBULIN A TEST SYSTEM
(FDA 510(k) Clearance)

K990552 · Dade Behring, Inc. · Immunology

Mar 1999

Decision

31d

Days

Class 2

Risk

K990552 is an FDA 510(k) clearance for the IMMUNOGLOBULIN A TEST SYSTEM. This device is classified as a Radioimmunoassay, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFQ).

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on March 25, 1999, 31 days after receiving the submission on February 22, 1999.

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

Submission Details

510(k) Number	K990552 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 1999
Decision Date	March 25, 1999
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF