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 IGG EIA TEST KIT (AMENDMENT)

K-Number: K862216 · 1986-06-30

ApplicantLabsystems, Inc.
Decision Date1986-06-30
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) is the device name listed in this FDA 510(k) record. The listed applicant is Labsystems, Inc.. It received FDA 510(k) clearance on 1986-06-30 under 510(k) number K862216. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)?

TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) is a medical device that received FDA 510(k) clearance on 1986-06-30. The listed applicant is Labsystems, Inc.. The 510(k) number is K862216.

When did TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) receive FDA 510(k) clearance?

TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) received FDA 510(k) clearance on 1986-06-30, under 510(k) number K862216.

Who is the listed applicant for TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)?

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

What is the FDA product code for TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)?

The FDA product code for TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT) is LGD.

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 Labsystems, 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.

K923365TILT/REDUCED SHEAR SEMI-RECLINE SEATING SYSTEMK896474RESUBMITTED FECATWIN SENSITIVE - FECA-EIAK890154MODIFIED LABYSYSTEMS' TOXOPLASMA GONDII IGG EIAK890091MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KITK881243RUBELLA IGG - EIA TEST KIT NUMBER 61 07 201K873780MODIFICATION RUBELLA IGM EIA TEST KIT

View all 17 devices →

Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, Inc.

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.

↑