Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

K-Number: K013568 · 2001-12-21

ApplicantBayer Corp.
Decision Date2001-12-21
Product CodeDHX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 2001-12-21 under 510(k) number K013568. 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 CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM?

CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2001-12-21. The listed applicant is Bayer Corp.. The 510(k) number is K013568.

When did CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM receive FDA 510(k) clearance?

CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM received FDA 510(k) clearance on 2001-12-21, under 510(k) number K013568.

Who is the listed applicant for CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM?

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

What is the FDA product code for CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM?

The FDA product code for CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM 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 Bayer 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.

K024062ASCENSIA BREEZE BLOOD GLUCOSE METERK023944BAYER DIAGNOSTICS CLINITEST PREGNANCY TESTK024017BAYER ADVIA CENTAUR HER-2/NEU ASSAYK024234ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONALK022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMK023584ASCENSIA DEX 2 DIABETES CARE SYSTEM

View all 96 devices →

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.

↑