510(k) K052017
- Device
- CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
- Applicant
- DADE BEHRING, INC.
- 510(k) number
- K052017
- Product code
- MKW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-09-01
- Date received
- 2005-07-26
- Regulation
- 862.1235
- Classification name
- Cyclosporine
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDREA M TASKER
- Address
- Glasgow Business Community; Bldg. 500 Mail Box 514 P.O. Box 6101, Newark DE US 19714 19714
FDA Registration Numbers#
- 1643621
- 9610126
- 1415939
- 3010939897
- 3010825766
- 2517506
- 2521625
- 3005333358
- 2432235
- 1219913
Source Documents#
Other 510(k) Records For Product Code MKW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K071455 | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR | Siemens Medical Solutions Diagnostics | 2008-09-11 |
| K080751 | ARCHITECT CYCLOSPORINE | Fujirebio Diagnostics,Inc. | 2008-09-11 |
| K081992 | DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 | Siemens Healthcare Diagnostics, Inc. | 2008-08-05 |
| K062236 | DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2006-08-21 |
| K053061 | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY | Dade Behring, Inc. | 2006-02-06 |
| K040761 | AXSYM CYCLOSPORINE | Abbott Laboratories, Inc. | 2004-04-30 |
| K023208 | CEDIA CYCLOSPORINE PLUS ASSAY | Microgenics Corp. | 2002-10-24 |
| K023065 | CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2002-10-16 |
Legacy Summary#
summary
FDA Review#
Decision Summary