Panels › Microbiology › Product code LKQ · Class 2
Antibody Igm,If, Cytomegalovirus Virus
Regulation 866.3175
0510(k)s in 12 months (18 all time)
0recalls in 12 months (8 all time)
5recalls that name a 510(k)
Top companies in LKQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Healthcare Diagnostics | 1 | 2 |
| Abbott Laboratories | 1 | 1 |
| Biomerieux Inc | 0 | 2 |
| Immuno Concepts, Inc. | 2 | 0 |
| QIAGEN Gaithersburg, Inc. | 0 | 2 |
| Whittaker Bioproducts, Inc. | 2 | 0 |
| Baxter Diagnostics, Inc. | 1 | 0 |
| Behring Diagnostics, Inc. | 1 | 0 |
| Biomerieux Vitek, Inc. | 1 | 0 |
| Boston Biomedica, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 13, 2010 | K100433 | IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, Siemens Healthcare Diagnostics | LKQ |
| Aug 22, 1997 | K972884 | ACCURUN 146 CMV IGM POSITIVE CONTROL Boston Biomedica, Inc. | LKQ |
| Aug 2, 1994 | K933549 | VIDAS CMV IGM ASSAY Biomerieux Vitek, Inc. | LKQ |
| Apr 8, 1993 | K922580 | BARTELS CYTOMEGALOVIRUS IGM EIA Baxter Diagnostics, Inc. | LKQ |
| Mar 4, 1992 | K914789 | ELISA CMV IGM Sclavo, Inc. | LKQ |
| Oct 28, 1991 | K913080 | OPUS(R) ANTI CMV-M Pb Diagnostics, Inc. | LKQ |
| Apr 26, 1990 | K900743 | CMV-IGM IFA TEST SYSTEM Zeus Scientific, Inc. | LKQ |
| Jul 25, 1989 | K893465 | CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) Immuno Concepts, Inc. | LKQ |
| Jul 14, 1989 | K893466 | CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) Immuno Concepts, Inc. | LKQ |
| May 13, 1988 | K872881 | ABBOTT CMV-M EIA KIT Abbott Laboratories | LKQ |
| Jan 11, 1988 | K872942 | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 Clinical Sciences, Inc. | LKQ |
| Aug 7, 1987 | K871832 | CMV IGM MICROASSAY Diamedix Corp. | LKQ |
| Apr 14, 1987 | K863798 | FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES Whittaker Bioproducts, Inc. | LKQ |
| Jul 21, 1986 | K861363 | ENZYGNOST ANTI-CMV IGM TEST Behring Diagnostics, Inc. | LKQ |
| May 13, 1986 | K860450 | THE CMV-IGM TEST Microbiological Research Corp. | LKQ |
| Apr 21, 1986 | K853889 | CORDIA CMV-M Cordis Corp. | LKQ |
| Feb 4, 1986 | K854839 | CYTOMEGELISA M TEST KIT Whittaker Bioproducts, Inc. | LKQ |
| Oct 27, 1983 | K831711 | CMV IGM TEST Gull Laboratories, Inc. | LKQ |
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