Cetus CMV Iha

FDA 510(k) K822965 · Cetus Corp.

Substantially Equivalent

510(k) numberK822965

Submission

Device name
Cetus CMV Iha
Applicant
Cetus Corp.
Mchenry, IL, US
Received
October 7, 1982
Decision date
February 15, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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K955799Copalis CMV Total Antibody AssayLJO · Traditional Sienna Biotech, Inc.07/10/1996SE
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K910003Cytomegalovirus Antibody ScreenLJO · Traditional Immucor, Inc.03/20/1991SE
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Questions and answers

When was Cetus CMV Iha cleared by the FDA?

Cetus CMV Iha (K822965) received a 510(k) decision of Substantially Equivalent on February 15, 1983, 131 days after the submission was received.

What is the product code of K822965?

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