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FDA 510(k)

TOXOPLASMA IGM IFA TEST SYSTEM

K-Number: K924882 · 1993-03-23

ApplicantZeus Scientific, Inc.
Decision Date1993-03-23
Product CodeGLZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOPLASMA IGM IFA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 1993-03-23 under 510(k) number K924882. The device is classified under product code GLZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXOPLASMA IGM IFA TEST SYSTEM?

TOXOPLASMA IGM IFA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1993-03-23. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K924882.

When did TOXOPLASMA IGM IFA TEST SYSTEM receive FDA 510(k) clearance?

TOXOPLASMA IGM IFA TEST SYSTEM received FDA 510(k) clearance on 1993-03-23, under 510(k) number K924882.

Who is the listed applicant for TOXOPLASMA IGM IFA TEST SYSTEM?

The FDA 510(k) record lists Zeus Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOXOPLASMA IGM IFA TEST SYSTEM?

The FDA product code for TOXOPLASMA IGM IFA TEST SYSTEM is GLZ.

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Other records listing Zeus Scientific, Inc. 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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Related Devices (Code: GLZ)

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.

K880007TOXO IGM TESTGull Laboratories, Inc.K850591FIAX TOXO-M ANTIBODIES TEST KITIntl. Diagnostic TechnologyK844287ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDIIApple Diagnostic ProductsK842664ANTI-TOXOPLASMA GONDII KITAmico Lab, Inc.K832900IMMUNOENZYME TEST SYS-DETECT-IGM ANTIBionetic Laboratory ProductsK830869POLYCHACO INDIRECT IMMUNOFLUORESCENCEParasitic Disease Consultants

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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