BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT— 510(k) K912150

Name: FDA 510(k) clearance K912150
Creator: U.S. Food and Drug Administration
Published: 1991-07-17

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K912150 for BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT, Substantially Equivalent on 1991-07-17. Applicant: Beckman Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1991-05-15
Decision date: 1991-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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