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FDA 510(k)

ACS:CENTAUR CEA

K-Number: K981478 · 1998-08-12

ApplicantChiron Diagnostics Corp.
Decision Date1998-08-12
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACS:CENTAUR CEA is the device name listed in this FDA 510(k) record. The listed applicant is Chiron Diagnostics Corp.. It received FDA 510(k) clearance on 1998-08-12 under 510(k) number K981478. The device is classified under product code DHX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACS:CENTAUR CEA?

ACS:CENTAUR CEA is a medical device that received FDA 510(k) clearance on 1998-08-12. The listed applicant is Chiron Diagnostics Corp.. The 510(k) number is K981478.

When did ACS:CENTAUR CEA receive FDA 510(k) clearance?

ACS:CENTAUR CEA received FDA 510(k) clearance on 1998-08-12, under 510(k) number K981478.

Who is the listed applicant for ACS:CENTAUR CEA?

The FDA 510(k) record lists Chiron Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACS:CENTAUR CEA?

The FDA product code for ACS:CENTAUR CEA is DHX.

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Other records listing Chiron Diagnostics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992157CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAYK991582CHIRON DIAGNOSTICS ACS: 180 FOLATEK991692CHIRON DIAGNOSTICS ACS: 180 FT3K982680CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAYK981839ACS:CENTAUR PSA2 IMMUNOASSAYK981592ACS:CENTAUR AFP

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Related Devices (Code: DHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223921Access CEABeckman Coulter, Inc.K231517VITROS Immunodiagnostic Products CEA Reagent PackOrtho Clinical DiagnosticsK200215ADVIA Centaur CEA AssaySiemens Healthcare Disgnostics, Inc.K081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENOlympus America, Inc.K080194VIDAS CEA (S) ASSAYbioMerieux, Inc.K071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)Dade Behring, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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