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)

CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY

K-Number: K863363 · 1986-11-13

ApplicantCytotech, Inc.
Decision Date1986-11-13
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Cytotech, Inc.. It received FDA 510(k) clearance on 1986-11-13 under 510(k) number K863363. 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 CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY?

CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Cytotech, Inc.. The 510(k) number is K863363.

When did CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1986-11-13, under 510(k) number K863363.

Who is the listed applicant for CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY?

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

What is the FDA product code for CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY?

The FDA product code for CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY 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 Cytotech, 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.

K882829CIRCULATING IMMUNE COMPLEXES CONTROLSK874379CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAYK873249ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLSK872426CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAYK871801CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KITK864315CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY

View all 10 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.

↑