LKQ — Antibody Igm,If, Cytomegalovirus Virus Class II
FDA Device Classification
Classification Details
- Product Code
- LKQ
- Device Class
- Class II
- Regulation Number
- 866.3175
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K100433 | siemens healthcare diagnostics | IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUS | May 13, 2010 |
| K972884 | boston biomedica | ACCURUN 146 CMV IGM POSITIVE CONTROL | August 22, 1997 |
| K933549 | biomerieux vitek | VIDAS CMV IGM ASSAY | August 2, 1994 |
| K922580 | baxter diagnostics | BARTELS CYTOMEGALOVIRUS IGM EIA | April 8, 1993 |
| K914789 | sclavo | ELISA CMV IGM | March 4, 1992 |
| K913080 | pb diagnostics | OPUS(R) ANTI CMV-M | October 28, 1991 |
| K900743 | zeus scientific | CMV-IGM IFA TEST SYSTEM | April 26, 1990 |
| K893465 | immuno concepts | CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | July 25, 1989 |
| K893466 | immuno concepts | CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) | July 14, 1989 |
| K872881 | abbott laboratories | ABBOTT CMV-M EIA KIT | May 13, 1988 |
| K872942 | clinical sciences | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 | January 11, 1988 |
| K871832 | diamedix | CMV IGM MICROASSAY | August 7, 1987 |
| K863798 | whittaker bioproducts | FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES | April 14, 1987 |
| K861363 | behring diagnostics | ENZYGNOST ANTI-CMV IGM TEST | July 21, 1986 |
| K860450 | microbiological research | THE CMV-IGM TEST | May 13, 1986 |
| K853889 | cordis | CORDIA CMV-M | April 21, 1986 |
| K854839 | whittaker bioproducts | CYTOMEGELISA M TEST KIT | February 4, 1986 |
| K831711 | gull laboratories | CMV IGM TEST | October 27, 1983 |