ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY— 510(k) K772250

Name: FDA 510(k) clearance K772250
Creator: U.S. Food and Drug Administration
Published: 1977-12-22

Substantially Equivalent

Kallestad Laboratories, Inc.

FDA 510(k) clearance K772250 for ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY, Substantially Equivalent on 1977-12-22. Applicant: Kallestad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kallestad Laboratories, Inc.
Product code: Code DEI
Device class: Class 2
Regulation: 21 CFR 866.5130
Advisory panel: Immunology
Date received: 1977-12-09
Decision date: 1977-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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