510(k) K100433
- Device
- IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS
- 510(k) number
- K100433
- Product code
- LKQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-05-13
- Date received
- 2010-02-16
- Regulation
- 866.3175
- Classification name
- Antibody Igm,if, Cytomegalovirus Virus
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT C EUSEBIO
- Address
- 1584 Enterprise Blvd. West Sacramento CA US 95691 95691
FDA Registration Numbers#
- 2915274
- 3005360469
- 8020790
- 3007088335
- 2242436
- 2432235
- 2029372
- 3032705
- 3002806944
- 1219913
Source Documents#
Other 510(k) Records For Product Code LKQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972884 | ACCURUN 146 CMV IGM POSITIVE CONTROL | Boston Biomedica, Inc. | 1997-08-22 |
| K933549 | VIDAS CMV IGM ASSAY | Biomerieux Vitek, Inc. | 1994-08-02 |
| K922580 | BARTELS CYTOMEGALOVIRUS IGM EIA | Baxter Diagnostics, Inc. | 1993-04-08 |
| K914789 | ELISA CMV IGM | Sclavo, Inc. | 1992-03-04 |
| K913080 | OPUS(R) ANTI CMV-M | Pb Diagnostics, Inc. | 1991-10-28 |
| K900743 | CMV-IGM IFA TEST SYSTEM | Zeus Scientific, Inc. | 1990-04-26 |
| K893465 | CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | Immuno Concepts, Inc. | 1989-07-25 |
| K893466 | CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) | Immuno Concepts, Inc. | 1989-07-14 |
| K872881 | ABBOTT CMV-M EIA KIT | Abbott Laboratories | 1988-05-13 |
| K872942 | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 | Clinical Sciences, Inc. | 1988-01-11 |
| K871832 | CMV IGM MICROASSAY | Diamedix Corp. | 1987-08-07 |
| K863798 | FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES | Whittaker Bioproducts, Inc. | 1987-04-14 |
| K861363 | ENZYGNOST ANTI-CMV IGM TEST | Behring Diagnostics, Inc. | 1986-07-21 |
| K860450 | THE CMV-IGM TEST | Microbiological Research Corp. | 1986-05-13 |
| K853889 | CORDIA CMV-M | Cordis Corp. | 1986-04-21 |
Legacy Summary#
summary
FDA Review#
Decision Summary