Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN

K-Number: K894261 · 1989-10-16

ApplicantMicrobix Biosystems, Inc.
Decision Date1989-10-16
Product CodeGMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is Microbix Biosystems, Inc.. It received FDA 510(k) clearance on 1989-10-16 under 510(k) number K894261. 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-CF ANTIGEN AND CONTROL ANTIGEN?

TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN is a medical device that received FDA 510(k) clearance on 1989-10-16. The listed applicant is Microbix Biosystems, Inc.. The 510(k) number is K894261.

When did TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN receive FDA 510(k) clearance?

TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN received FDA 510(k) clearance on 1989-10-16, under 510(k) number K894261.

Who is the listed applicant for TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN?

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

What is the FDA product code for TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN?

The FDA product code for TOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGEN 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 Microbix Biosystems, 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.

K894262RUBELLA ANTIGEN AND CONTROL ANTIGENK852930VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTROK852929CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTRK852932MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLTK852931HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLTK852933MYCOPLASMA SPP SEROLOGICAL REAGENTS

View all 7 devices →

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.

K864981TOXOPLASMA GONDIIVirion (U.S.), 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.

↑