BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY— 510(k) K801750

Name: FDA 510(k) clearance K801750
Creator: U.S. Food and Drug Administration
Published: 1980-09-16

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K801750 for BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY, Substantially Equivalent on 1980-09-16. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code CIX
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 1980-07-28
Decision date: 1980-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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