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FDA 510(k)

IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT

K-Number: K980855 · 1998-04-21

ApplicantDpc Cirrus
Decision Date1998-04-21
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dpc Cirrus. It received FDA 510(k) clearance on 1998-04-21 under 510(k) number K980855. 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 IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT?

IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Dpc Cirrus. The 510(k) number is K980855.

When did IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT receive FDA 510(k) clearance?

IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT received FDA 510(k) clearance on 1998-04-21, under 510(k) number K980855.

Who is the listed applicant for IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT?

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

What is the FDA product code for IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT?

The FDA product code for IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT is DHX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dpc Cirrus 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.

K970227IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER

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

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

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