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FDA 510(k)

COPALIS TORC TOTAL ANTIBODY ASSAY

K-Number: K970931 · 1997-04-24

ApplicantSienna Biotech, Inc.
Decision Date1997-04-24
Product CodeLQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COPALIS TORC 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 1997-04-24 under 510(k) number K970931. 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 TORC TOTAL ANTIBODY ASSAY?

COPALIS TORC TOTAL ANTIBODY ASSAY is a medical device that received FDA 510(k) clearance on 1997-04-24. The listed applicant is Sienna Biotech, Inc.. The 510(k) number is K970931.

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

COPALIS TORC TOTAL ANTIBODY ASSAY received FDA 510(k) clearance on 1997-04-24, under 510(k) number K970931.

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

The FDA product code for COPALIS TORC TOTAL ANTIBODY ASSAY 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.

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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.

K961784COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYSK955799COPALIS 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.,K961784COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYSSienna Biotech, Inc.K954920MUREX RUB-EXMurex Diagnostics, Inc.K952544COLORSLIDER RUBELLASeradyn, Inc.K912391RUBALEX, MODIFICATIONOrion Corp.K901637RESUBMITTED MODIFIED RUBALEXOrion Corp.

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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