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FDA 510(k)

TOXOPLASMA GONDII

K-Number: K864981 · 1987-10-30

ApplicantVirion (U.S.), Inc.
Decision Date1987-10-30
Product CodeGMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOPLASMA GONDII is the device name listed in this FDA 510(k) record. The listed applicant is Virion (U.S.), Inc.. It received FDA 510(k) clearance on 1987-10-30 under 510(k) number K864981. The device is classified under product code GMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXOPLASMA GONDII?

TOXOPLASMA GONDII is a medical device that received FDA 510(k) clearance on 1987-10-30. The listed applicant is Virion (U.S.), Inc.. The 510(k) number is K864981.

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

TOXOPLASMA GONDII received FDA 510(k) clearance on 1987-10-30, under 510(k) number K864981.

Who is the listed applicant for TOXOPLASMA GONDII?

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

What is the FDA product code for TOXOPLASMA GONDII?

The FDA product code for TOXOPLASMA GONDII is GMN.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Virion (U.S.), 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.

K933251EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TESTK921618COXSACKIE VIRUS B1-B6 CF ANTIGENSK905306MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGENK905385P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN

Related Devices (Code: GMN)

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.

K894261TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGENMicrobix Biosystems, Inc.K791456AGGLUTINOTEST-TOXOPLASMOSISVolu Sol Medical Industries

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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