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FDA 510(k)

TOXO IGM TEST

K-Number: K880007 · 1988-03-17

ApplicantGull Laboratories, Inc.
Decision Date1988-03-17
Product CodeGLZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXO IGM TEST is the device name listed in this FDA 510(k) record. The listed applicant is Gull Laboratories, Inc.. It received FDA 510(k) clearance on 1988-03-17 under 510(k) number K880007. 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 TOXO IGM TEST?

TOXO IGM TEST is a medical device that received FDA 510(k) clearance on 1988-03-17. The listed applicant is Gull Laboratories, Inc.. The 510(k) number is K880007.

When did TOXO IGM TEST receive FDA 510(k) clearance?

TOXO IGM TEST received FDA 510(k) clearance on 1988-03-17, under 510(k) number K880007.

Who is the listed applicant for TOXO IGM TEST?

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

What is the FDA product code for TOXO IGM TEST?

The FDA product code for TOXO IGM TEST is GLZ.

Other records listing Gull Laboratories, 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.

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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.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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