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)

COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY

K-Number: K992552 · 1999-12-16

ApplicantDiaSorin, Inc.
Decision Date1999-12-16
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 1999-12-16 under 510(k) number K992552. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY?

COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY is a medical device that received FDA 510(k) clearance on 1999-12-16. The listed applicant is DiaSorin, Inc.. The 510(k) number is K992552.

When did COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY receive FDA 510(k) clearance?

COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY received FDA 510(k) clearance on 1999-12-16, under 510(k) number K992552.

Who is the listed applicant for COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY?

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

What is the FDA product code for COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY?

The FDA product code for COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY is LIP.

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 DiaSorin, 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.

K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXK231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HTK223403LIAISON Anti-HAV; LIAISON XSK213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusK213936LIAISON MeMed BV, LIAISON MeMed BV Control SetK193650LIAISON Ferritin

View all 66 devices →

Related Devices (Code: LIP)

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.

K241427Access SyphilisBeckman Coulter, Inc.K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical DiagnosticsK211302Elecsys SyphilisRoche DiagnosticsK170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetBio-Rad LaboratoriesK160910Elecsys SyphilisRoche DiagnosticsK153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,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.

↑