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FDA 510(k)

FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO

K-Number: K790464 · 1979-06-13

ApplicantIntl. Diagnostic Technology
Decision Date1979-06-13
Product CodeGLZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Technology. It received FDA 510(k) clearance on 1979-06-13 under 510(k) number K790464. 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 FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO?

FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO is a medical device that received FDA 510(k) clearance on 1979-06-13. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K790464.

When did FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO receive FDA 510(k) clearance?

FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO received FDA 510(k) clearance on 1979-06-13, under 510(k) number K790464.

Who is the listed applicant for FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO?

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

What is the FDA product code for FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO?

The FDA product code for FIAX TEST KIT FOR ANTI-TOXOPLASMA ANTIBO is GLZ.

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Other records listing Intl. Diagnostic Technology 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.

K850591FIAX TOXO-M ANTIBODIES TEST KITK843570FIAX HAPTOGLOBIN TEST KITK843621FIAX 420 DILUTORK843356FIAX 100 FLUOROMETERK842749FIAX TOTAL IGE TEST KITK842071FIAX TRANSFERRIN TEST KIT

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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.

K924882TOXOPLASMA IGM IFA TEST SYSTEMZeus Scientific, Inc.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 Products

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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