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FDA 510(k)

AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

K-Number: K972462 · 1997-09-22

ApplicantBayer Corp.
Decision Date1997-09-22
Product CodeLOJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AFP ASSAY FOR THE BAYER IMMUNO 1 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 1997-09-22 under 510(k) number K972462. The device is classified under product code LOJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM?

AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-22. The listed applicant is Bayer Corp.. The 510(k) number is K972462.

When did AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM receive FDA 510(k) clearance?

AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM received FDA 510(k) clearance on 1997-09-22, under 510(k) number K972462.

Who is the listed applicant for AFP ASSAY FOR THE BAYER IMMUNO 1 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 AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM?

The FDA product code for AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM is LOJ.

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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: LOJ)

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.

K220176Elecsys AFPRoche DiagnosticsK213626VITROS AFPOrtho Clinical DiagnosticsK090236DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454Siemens Healthcare DiagnosticsK081709OLYMPUS AFP - ALPHA-FETOPROTEINOlympus Life Science Research Europa GmbH (Europa)K080017VIDAS AFP ASSAYbioMerieux, Inc.K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600Dade 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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