CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER— 510(k) K971418

Name: FDA 510(k) clearance K971418
Creator: U.S. Food and Drug Administration
Published: 1997-07-17

Substantially Equivalent

Chiron Diagnostics Corp.

FDA 510(k) clearance K971418 for CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER, Substantially Equivalent on 1997-07-17. Applicant: Chiron Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Chiron Diagnostics Corp.
Product code: Code MOI
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1997-04-16
Decision date: 1997-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K971418

K-number listed on FDA's recall record

Z-1553-2014 — ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.Class II·Terminated·Siemens Healthcare Diagnostics·20140218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971418.

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