Cmvgen
FDA 510(k) K974456 · Instrumentation Laboratory CO
510(k) numberK974456
Submission
- Device name
- Cmvgen
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- November 25, 1997
- Decision date
- May 1, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LJO – Antigen, Iha, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Specialty
- Microbiology
Other 510(k)s with product code LJO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203612 | Capture-CMVLJO · Traditional | Immucor, Inc. | 03/22/2021SE |
| K183571 | Capture-CMVLJO · Traditional | Immucor, Inc. | 02/04/2019SE |
| K001767 | Diamedix Is-Cmv Igm Capture Test SystemLJO · Traditional | Diamedix Corp. | 08/07/2000SE |
| K974901 | Hybrid Capture System CMV DNA AssayLJO · Traditional | Digene Corp. | 09/29/1998SE |
| K951851 | Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence AssayLJO · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 07/24/1996SE |
| K955799 | Copalis CMV Total Antibody AssayLJO · Traditional | Sienna Biotech, Inc. | 07/10/1996SE |
| K920222 | Healthtest Assay for Antibody to CytomegalovirusLJO · Traditional | Akers Research Corp. | 07/27/1992SE |
| K910003 | Cytomegalovirus Antibody ScreenLJO · Traditional | Immucor, Inc. | 03/20/1991SE |
| K852494 | Cmv-IhaLJO · Traditional | Hillcrest Biologicals | 09/16/1985SE |
| K841520 | CMV Latex Agglutination Test KitLJO · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/07/1984SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K233790 | Acl Top 970 CLJPA · Special | 12/29/2023SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | 12/13/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | 09/29/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | 08/16/2022SE |
Questions and answers
When was Cmvgen cleared by the FDA?
Cmvgen (K974456) received a 510(k) decision of Substantially Equivalent on May 1, 1998, 157 days after the submission was received.
What is the product code of K974456?
The FDA product code is LJO – Antigen, Iha, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.