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FDA 510(k)

COPALIS CMV TOTAL ANTIBODY ASSAY

K-Number: K955799 · 1996-07-10

ApplicantSienna Biotech, Inc.
Decision Date1996-07-10
Product CodeLJO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COPALIS CMV TOTAL ANTIBODY ASSAY 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 1996-07-10 under 510(k) number K955799. The device is classified under product code LJO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPALIS CMV TOTAL ANTIBODY ASSAY?

COPALIS CMV TOTAL ANTIBODY ASSAY is a medical device that received FDA 510(k) clearance on 1996-07-10. The listed applicant is Sienna Biotech, Inc.. The 510(k) number is K955799.

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

COPALIS CMV TOTAL ANTIBODY ASSAY received FDA 510(k) clearance on 1996-07-10, under 510(k) number K955799.

Who is the listed applicant for COPALIS CMV TOTAL ANTIBODY ASSAY?

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 CMV TOTAL ANTIBODY ASSAY?

The FDA product code for COPALIS CMV TOTAL ANTIBODY ASSAY is LJO.

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.

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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 ASSAYK961784COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS

Related Devices (Code: LJO)

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.

K203612Capture-CMVImmucor, Inc.K183571Capture-CMVImmucor, Inc.K001767DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEMDiamedix Corp.K974901HYBRID CAPTURE SYSTEM CMV DNA ASSAYDigene Corp.K974456CMVGENInstrumentation Laboratory COK951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYE.I. Dupont DE Nemours & Co., 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.

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