LKQ — Antibody Igm,If, Cytomegalovirus Virus Class II
FDA product code LKQ covers "Antibody Igm,If, Cytomegalovirus Virus", a Class II medical device regulated under 21 CFR 866.3175. Submissions are reviewed by the Microbiology panel. At least 18 recent 510(k) clearances have been granted under this product code.
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 |