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FDA 510(k)

COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS

K-Number: K961784 · 1996-10-31

ApplicantSienna Biotech, Inc.
Decision Date1996-10-31
Product CodeLQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS is the device name listed in this FDA 510(k) record. The listed applicant is Sienna Biotech, Inc.. It received FDA 510(k) clearance on 1996-10-31 under 510(k) number K961784. The device is classified under product code LQN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS?

COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS is a medical device that received FDA 510(k) clearance on 1996-10-31. The listed applicant is Sienna Biotech, Inc.. The 510(k) number is K961784.

When did COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS receive FDA 510(k) clearance?

COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS received FDA 510(k) clearance on 1996-10-31, under 510(k) number K961784.

Who is the listed applicant for COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS?

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

What is the FDA product code for COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS?

The FDA product code for COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS is LQN.

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 Sienna Biotech, 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.

K970931COPALIS TORC TOTAL ANTIBODY ASSAYK955799COPALIS CMV TOTAL ANTIBODY ASSAY

Related Devices (Code: LQN)

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.

K031490RUBELLACOLImmunostics Inc.,K970931COPALIS TORC TOTAL ANTIBODY ASSAYSienna Biotech, Inc.K954920MUREX RUB-EXMurex Diagnostics, Inc.K952544COLORSLIDER RUBELLASeradyn, Inc.K912391RUBALEX, MODIFICATIONOrion Corp.K901637RESUBMITTED MODIFIED RUBALEXOrion Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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