Cmv-Iha

FDA 510(k) K852494 · Hillcrest Biologicals

Substantially Equivalent

510(k) numberK852494

Submission

Device name
Cmv-Iha
Applicant
Hillcrest Biologicals
Cypress, CA, US
Received
June 12, 1985
Decision date
September 16, 1985
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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K001767Diamedix Is-Cmv Igm Capture Test SystemLJO · Traditional Diamedix Corp.08/07/2000SE
K974901Hybrid Capture System CMV DNA AssayLJO · Traditional Digene Corp.09/29/1998SE
K974456CmvgenLJO · Traditional Instrumentation Laboratory CO05/01/1998SE
K951851Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence AssayLJO · Traditional E.I. Dupont DE Nemours & Co., Inc.07/24/1996SE
K955799Copalis CMV Total Antibody AssayLJO · Traditional Sienna Biotech, Inc.07/10/1996SE
K920222Healthtest Assay for Antibody to CytomegalovirusLJO · Traditional Akers Research Corp.07/27/1992SE
K910003Cytomegalovirus Antibody ScreenLJO · Traditional Immucor, Inc.03/20/1991SE
K841520CMV Latex Agglutination Test KitLJO · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic09/07/1984SE

More from Bd Becton Dickinson Vacutainer Systems Preanalytic

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K913617Arbovirus Igg Ifa TestGQC · Traditional 12/03/1992SE
K922374Q Fever Igm Ifa TestGPJ · Traditional 10/21/1992SE
K913906Q Fever Igg Ifa TestGPJ · Traditional 10/21/1992SE
K900206Lyme Disease Igm ElisaLSR · Traditional 06/28/1991SE
K896594Ebv Vca Antibody (Igm)LJN · Traditional 01/16/1990SE
K884829Ebv Early Antigen (R+D)JRY · Traditional 04/12/1989SE
K883767Lyme Disease Ifa (Igm)LSR · Traditional 03/15/1989SE
K884591Ebv-Vca Antibody (Igg)GNP · Traditional 01/24/1989SE
K883487Lyme Disease Ifa (Igg)LSR · Traditional 12/13/1988SE

Questions and answers

When was Cmv-Iha cleared by the FDA?

Cmv-Iha (K852494) received a 510(k) decision of Substantially Equivalent on September 16, 1985, 96 days after the submission was received.

What is the product code of K852494?

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