Cleared Traditional

ACS:CENTAUR CEA

K981478 · Chiron Diagnostics Corp. · Immunology
Aug 1998
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K981478 is an FDA 510(k) clearance for the ACS:CENTAUR CEA, a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on August 12, 1998, 110 days after receiving the submission on April 24, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K981478 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1998
Decision Date August 12, 1998
Days to Decision 110 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHX — System, Test, Carcinoembryonic Antigen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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