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FDA 510(k)

TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM

K-Number: K955760 · 1996-08-02

ApplicantBayer Corp.
Decision Date1996-08-02
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOPLASMA IGG IN-VITRO DIAGNOSTIC 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 1996-08-02 under 510(k) number K955760. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM?

TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1996-08-02. The listed applicant is Bayer Corp.. The 510(k) number is K955760.

When did TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM receive FDA 510(k) clearance?

TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM received FDA 510(k) clearance on 1996-08-02, under 510(k) number K955760.

Who is the listed applicant for TOXOPLASMA IGG IN-VITRO DIAGNOSTIC 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 TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM?

The FDA product code for TOXOPLASMA IGG IN-VITRO DIAGNOSTIC SYSTEM is LGD.

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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

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Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, 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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