Copalis CMV Total Antibody Assay

FDA 510(k) K955799 · Sienna Biotech, Inc.

Substantially Equivalent

510(k) numberK955799

Submission

Device name
Copalis CMV Total Antibody Assay
Applicant
Sienna Biotech, Inc.
Bethesda, MD, US
Received
December 22, 1995
Decision date
July 10, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LJO – Antigen, Iha, Cytomegalovirus
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3175
Specialty
Microbiology

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More from Bd Becton Dickinson Vacutainer Systems Preanalytic

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K970931Copalis Torc Total Antibody AssayLQN · Traditional 04/24/1997SE
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Questions and answers

When was Copalis CMV Total Antibody Assay cleared by the FDA?

Copalis CMV Total Antibody Assay (K955799) received a 510(k) decision of Substantially Equivalent on July 10, 1996, 201 days after the submission was received.

What is the product code of K955799?

The FDA product code is LJO – Antigen, Iha, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.