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FDA 510(k)

TOXELISA TEST KIT

K-Number: K781549 · 1978-12-07

ApplicantMicrobiological Assoc.
Decision Date1978-12-07
Product CodeGLZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXELISA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Microbiological Assoc.. It received FDA 510(k) clearance on 1978-12-07 under 510(k) number K781549. 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 TOXELISA TEST KIT?

TOXELISA TEST KIT is a medical device that received FDA 510(k) clearance on 1978-12-07. The listed applicant is Microbiological Assoc.. The 510(k) number is K781549.

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

TOXELISA TEST KIT received FDA 510(k) clearance on 1978-12-07, under 510(k) number K781549.

Who is the listed applicant for TOXELISA TEST KIT?

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

What is the FDA product code for TOXELISA TEST KIT?

The FDA product code for TOXELISA TEST KIT is GLZ.

Related Clinical Trials

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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Other records listing Microbiological Assoc. 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.

K792133RUBELISA TEST KITK791397HERPES EIA TEST KITK780996RUBELISA TEST KITK781392CYTOMEGILISH TEST KITK781143IMMUNOFLUORESCENCE TEST KITK770764TISSUE CULTURE MEDIA W/HEPES BUFFER

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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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