Cleared Traditional

CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY

K982680 · Chiron Diagnostics Corp. · Immunology
Oct 1998
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K982680 is an FDA 510(k) clearance for the CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY, a System, Test, Immunological, Antigen, Tumor (Class II — Special Controls, product code MOI), submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on October 15, 1998, 76 days after receiving the submission on July 31, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K982680 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1998
Decision Date October 15, 1998
Days to Decision 76 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOI — System, Test, Immunological, Antigen, Tumor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

Similar Devices — MOI System, Test, Immunological, Antigen, Tumor

All 27
Access BR Monitor
K240403 · Beckman Coulter, Inc. · May 2024
IMMULITE? 2000 BR-MA
K233946 · Siemens Healthcare Diagnostics Products, Ltd. · Mar 2024
Lumipulse G CA15-3
K192524 · Fujirebio Diagnostics,Inc. · Sep 2020
ADVIA Centaur BR
K193489 · Siemens Healthcare Diagnostics, Inc. · Feb 2020
ADVIA Centaur CA 15-3 assay
K192777 · Siemens Healthcare Diagnostics, Inc. · Nov 2019
Elecsys CA 15-3 II
K181492 · Roche Diagnostics · Jun 2018