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FDA 510(k)

FIAX TOXO-M ANTIBODIES TEST KIT

K-Number: K850591 · 1985-04-30

ApplicantIntl. Diagnostic Technology
Decision Date1985-04-30
Product CodeGLZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FIAX TOXO-M ANTIBODIES TEST KIT 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 1985-04-30 under 510(k) number K850591. 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 TOXO-M ANTIBODIES TEST KIT?

FIAX TOXO-M ANTIBODIES TEST KIT is a medical device that received FDA 510(k) clearance on 1985-04-30. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K850591.

When did FIAX TOXO-M ANTIBODIES TEST KIT receive FDA 510(k) clearance?

FIAX TOXO-M ANTIBODIES TEST KIT received FDA 510(k) clearance on 1985-04-30, under 510(k) number K850591.

Who is the listed applicant for FIAX TOXO-M ANTIBODIES TEST KIT?

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 TOXO-M ANTIBODIES TEST KIT?

The FDA product code for FIAX TOXO-M ANTIBODIES TEST KIT 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.

K843570FIAX HAPTOGLOBIN TEST KITK843621FIAX 420 DILUTORK843356FIAX 100 FLUOROMETERK842749FIAX TOTAL IGE TEST KITK842071FIAX TRANSFERRIN TEST KITK841174RUBELLA ANTIBODY FLUOROIMMUNOASSAY

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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.K844287ADPIFA 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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