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FDA 510(k)

TOXOPLASMA GONDII SEROLOGICAL REAGENTS

K-Number: K803134 · 1981-01-29

ApplicantMicrobiological Research Corp.
Decision Date1981-01-29
Product CodeGLZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOPLASMA GONDII SEROLOGICAL REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Microbiological Research Corp.. It received FDA 510(k) clearance on 1981-01-29 under 510(k) number K803134. 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 TOXOPLASMA GONDII SEROLOGICAL REAGENTS?

TOXOPLASMA GONDII SEROLOGICAL REAGENTS is a medical device that received FDA 510(k) clearance on 1981-01-29. The listed applicant is Microbiological Research Corp.. The 510(k) number is K803134.

When did TOXOPLASMA GONDII SEROLOGICAL REAGENTS receive FDA 510(k) clearance?

TOXOPLASMA GONDII SEROLOGICAL REAGENTS received FDA 510(k) clearance on 1981-01-29, under 510(k) number K803134.

Who is the listed applicant for TOXOPLASMA GONDII SEROLOGICAL REAGENTS?

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

What is the FDA product code for TOXOPLASMA GONDII SEROLOGICAL REAGENTS?

The FDA product code for TOXOPLASMA GONDII SEROLOGICAL REAGENTS is GLZ.

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Other records listing Microbiological Research Corp. 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.

K883011MRI NEO-TRYP TRYPSIN RIAK861120THE GOLDEN QUAD TEST (HSV)K861122THE GOLDEN QUAD TEST (TOXO)K861123THE GOLDEN QUAD TEST (CMV)K861121THE GOLDEN QUAD TEST (EBV)K860450THE CMV-IGM TEST

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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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