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)

QUANTA LITE TOXOPLASMA IGG

K-Number: K971441 · 1997-12-02

ApplicantInova Diagnostics, Inc.
Decision Date1997-12-02
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUANTA LITE TOXOPLASMA IGG is the device name listed in this FDA 510(k) record. The listed applicant is Inova Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-12-02 under 510(k) number K971441. 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 QUANTA LITE TOXOPLASMA IGG?

QUANTA LITE TOXOPLASMA IGG is a medical device that received FDA 510(k) clearance on 1997-12-02. The listed applicant is Inova Diagnostics, Inc.. The 510(k) number is K971441.

When did QUANTA LITE TOXOPLASMA IGG receive FDA 510(k) clearance?

QUANTA LITE TOXOPLASMA IGG received FDA 510(k) clearance on 1997-12-02, under 510(k) number K971441.

Who is the listed applicant for QUANTA LITE TOXOPLASMA IGG?

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

What is the FDA product code for QUANTA LITE TOXOPLASMA IGG?

The FDA product code for QUANTA LITE TOXOPLASMA IGG 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 Inova Diagnostics, 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.

K243979Aptiva APS IgA ReagentK223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentK213403Aptiva CTD Essential ReagentK200230Aptiva Celiac Disease IgG ReagentK193604Aptiva Celiac Disease IgA ReagentK192916NOVA Lite DAPI dsDNA Crithidia luciliae Kit

View all 127 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.

↑