QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK— 510(k) K894538

Name: FDA 510(k) clearance K894538
Creator: U.S. Food and Drug Administration
Published: 1989-08-04

Substantially Equivalent

Kallestad Diag, A Div. of Erbamont, Inc.

FDA 510(k) clearance K894538 for QM300 ALPHA1-ACID GLYCOPROTEIN ANTIBODY PACK, Substantially Equivalent on 1989-08-04. Applicant: Kallestad Diag, A Div. of Erbamont, Inc.. Device class: 1.

Clearance details

Applicant: Kallestad Diag, A Div. of Erbamont, Inc.
Product code: Code DBN
Device class: Class 1
Regulation: 21 CFR 866.5530
Advisory panel: Immunology
Date received: 1989-07-20
Decision date: 1989-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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