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FDA 510(k)

TOXOPLASMOSIS TEST KIT

K-Number: K811562 · 1981-07-16

ApplicantImmuno-Diagnostic Products, Inc.
Decision Date1981-07-16
Product CodeGLZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOPLASMOSIS TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Diagnostic Products, Inc.. It received FDA 510(k) clearance on 1981-07-16 under 510(k) number K811562. 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 TOXOPLASMOSIS TEST KIT?

TOXOPLASMOSIS TEST KIT is a medical device that received FDA 510(k) clearance on 1981-07-16. The listed applicant is Immuno-Diagnostic Products, Inc.. The 510(k) number is K811562.

When did TOXOPLASMOSIS TEST KIT receive FDA 510(k) clearance?

TOXOPLASMOSIS TEST KIT received FDA 510(k) clearance on 1981-07-16, under 510(k) number K811562.

Who is the listed applicant for TOXOPLASMOSIS TEST KIT?

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

What is the FDA product code for TOXOPLASMOSIS TEST KIT?

The FDA product code for TOXOPLASMOSIS TEST KIT is GLZ.

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Other records listing Immuno-Diagnostic Products, 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.

K854207EBV(EPSTEIN-BARR VIRUS) TEST KITK811021HERPESK811022ANA TEST KITK801963CMV TEST KITK801959FTA-ABS TESTK801961RF-II 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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