Cleared Traditional

QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK

K894538 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology

Aug 1989

Decision

15d

Days

Class 1

Risk

About This 510(k) Submission

K894538 is an FDA 510(k) clearance for the QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK, a Fc, Antigen, Antiserum, Control (Class I — General Controls, product code DBN), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on August 4, 1989, 15 days after receiving the submission on July 20, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5530.

Submission Details

510(k) Number	K894538 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 20, 1989
Decision Date	August 04, 1989
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—