ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)— 510(k) K980190

Name: FDA 510(k) clearance K980190
Creator: U.S. Food and Drug Administration
Published: 1998-03-06

Substantially Equivalent

Chiron Corp.

FDA 510(k) clearance K980190 for ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM), Substantially Equivalent on 1998-03-06. 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: 1998-01-20
Decision date: 1998-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emeryville, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MOI

view all

K240403 — Access BR Monitor2024-05-09
K233946 — IMMULITE® 2000 BR-MA2024-03-13
K192524 — Lumipulse G CA15-32020-09-04
K193489 — ADVIA Centaur BR2020-02-13
K192777 — ADVIA Centaur CA 15-3 assay2019-11-22

More clearances from Chiron Corp.

view all

K981698 — ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)1998-07-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.