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FDA 510(k)

ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII

K-Number: K844287 · 1985-01-07

ApplicantApple Diagnostic Products
Decision Date1985-01-07
Product CodeGLZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII is the device name listed in this FDA 510(k) record. The listed applicant is Apple Diagnostic Products. It received FDA 510(k) clearance on 1985-01-07 under 510(k) number K844287. 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 ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII?

ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII is a medical device that received FDA 510(k) clearance on 1985-01-07. The listed applicant is Apple Diagnostic Products. The 510(k) number is K844287.

When did ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII receive FDA 510(k) clearance?

ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII received FDA 510(k) clearance on 1985-01-07, under 510(k) number K844287.

Who is the listed applicant for ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII?

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

What is the FDA product code for ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII?

The FDA product code for ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII is GLZ.

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Other records listing Apple Diagnostic Products 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.

K843745ADP ANA APPLEZYMEK843120APPLELISA CHLAMYDIA TRACHOMATIS ANTIK842707ADP NDNA IFA TESTK842183ADP ANA IFA TESTK834241ANA APPLELISAK834242ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS

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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 TechnologyK842664ANTI-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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