IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)— 510(k) K964766

Name: FDA 510(k) clearance K964766
Creator: U.S. Food and Drug Administration
Published: 1997-04-25

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K964766 for IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT), Substantially Equivalent on 1997-04-25. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code DEM
Device class: Class 2
Regulation: 21 CFR 866.5130
Advisory panel: Immunology
Date received: 1996-11-27
Decision date: 1997-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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