ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)— 510(k) K981698

Name: FDA 510(k) clearance K981698
Creator: U.S. Food and Drug Administration
Published: 1998-07-10

Substantially Equivalent

Chiron Corp.

FDA 510(k) clearance K981698 for ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29), Substantially Equivalent on 1998-07-10. Applicant: Chiron Corp.. Device class: 2.

Clearance details

Applicant: Chiron Corp.
Product code: Code MOI
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1998-05-14
Decision date: 1998-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emeryville, CA, US

Download summary PDF View on FDA.gov ↗

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