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)

BAYER ADVIA CENTAUR CA 19-9 ASSAY

K-Number: K031393 · 2003-06-24

ApplicantBayer Healthcare, LLC
Decision Date2003-06-24
Product CodeNIG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BAYER ADVIA CENTAUR CA 19-9 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2003-06-24 under 510(k) number K031393. The device is classified under product code NIG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYER ADVIA CENTAUR CA 19-9 ASSAY?

BAYER ADVIA CENTAUR CA 19-9 ASSAY is a medical device that received FDA 510(k) clearance on 2003-06-24. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K031393.

When did BAYER ADVIA CENTAUR CA 19-9 ASSAY receive FDA 510(k) clearance?

BAYER ADVIA CENTAUR CA 19-9 ASSAY received FDA 510(k) clearance on 2003-06-24, under 510(k) number K031393.

Who is the listed applicant for BAYER ADVIA CENTAUR CA 19-9 ASSAY?

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

What is the FDA product code for BAYER ADVIA CENTAUR CA 19-9 ASSAY?

The FDA product code for BAYER ADVIA CENTAUR CA 19-9 ASSAY is NIG.

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 Healthcare, LLC 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.

K171802ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)K121190CONTOUR NEXT BLOOD GLUCOSE METERK110587CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW)K093930DIDGET WORLD REPORTSK090628DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080K090413A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC

View all 44 devices →

Related Devices (Code: NIG)

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.

K253528Atellica IM CA 19-9 IISiemens Healthcare Diagnostics, Inc.K231525VITROS Immunodiagnostic Products CA 19-9TM Reagent PackOrtho Clinical DiagnosticsK200997Lumipulse G CA19-9-NFujirebio Diagnostics,Inc.K191973Lumpipulse G CA19-9-NFujirebio Dianostics, Inc.K100375DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604Siemens Healthcare Diagnostics, Inc.K052889VITROS CA 19-9Fujirebio Diagnostics,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.

↑