Diamedix Is-Cmv Igm Capture Test System
FDA 510(k) K001767 · Diamedix Corp.
510(k) numberK001767
Submission
- Device name
- Diamedix Is-Cmv Igm Capture Test System
- Applicant
- Diamedix Corp.
Miami, FL, US - Received
- June 12, 2000
- Decision date
- August 7, 2000
- 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 |
| 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 |
| K841520 | CMV Latex Agglutination Test KitLJO · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/07/1984SE |
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|---|---|---|
| K093101 | Mago 4SLFX · Traditional | 01/21/2011SE |
| K021394 | Diamedix Is-Rheumatoid Factor Test SystemDHR · Traditional | 07/09/2002SE |
| K013956 | Diamedix IS-ANTI-B2 Glycoprotein I ScreenMSV · Traditional | 01/08/2002SE |
| K013628 | Diamedix IS-ANTI-B2 Glycoprotein I Igg/Igm Test SystemMSV · Traditional | 12/21/2001SE |
| K012450 | Diamedix Is-Anti-Cardiolipin Iga Test SystemMID · Traditional | 10/26/2001SE |
| K012449 | Diamedix Is-Anti-Cardiolipin Igg/Igm Test SystemMID · Traditional | 10/26/2001SE |
| K012797 | Diamedix Is-Anti-Gliadin Iga Test SystemMST · Traditional | 09/28/2001SE |
| K012795 | Diamedix Is-Anti-Gliadin Igg Test SystemMST · Traditional | 09/28/2001SE |
| K012053 | Diamedix Is-Anti-Cardiolipin Screen Test SystemMID · Traditional | 08/20/2001SE |
| K002262 | Diamedix Is-Hsv 1&2 Igm Test SystemLGC · Traditional | 11/28/2000SE |
Questions and answers
When was Diamedix Is-Cmv Igm Capture Test System cleared by the FDA?
Diamedix Is-Cmv Igm Capture Test System (K001767) received a 510(k) decision of Substantially Equivalent on August 7, 2000, 56 days after the submission was received.
What is the product code of K001767?
The FDA product code is LJO – Antigen, Iha, Cytomegalovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3175.