CMV Latex Agglutination Test Kit
FDA 510(k) K841520 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK841520
Submission
- Device name
- CMV Latex Agglutination Test Kit
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Walker, MI, US - Received
- April 12, 1984
- Decision date
- September 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| 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 |
| K974456 | CmvgenLJO · Traditional | Instrumentation Laboratory CO | 05/01/1998SE |
| 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 |
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Questions and answers
When was CMV Latex Agglutination Test Kit cleared by the FDA?
CMV Latex Agglutination Test Kit (K841520) received a 510(k) decision of Substantially Equivalent on September 7, 1984, 148 days after the submission was received.
What is the product code of K841520?
The FDA product code is LJO – Antigen, Iha, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.