FDA Product Code
FDA Product Code MKW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1235
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K071455 | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR | Siemens Medical Solutions Diagnostics | 2008-09-11 | Traditional | PDF ↗ |
| K080751 | ARCHITECT CYCLOSPORINE | Fujirebio Diagnostics,Inc. | 2008-09-11 | Traditional | PDF ↗ |
| K081992 | DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 | Siemens Healthcare Diagnostics, Inc. | 2008-08-05 | Special | PDF ↗ |
| K062236 | DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2006-08-21 | Special | PDF ↗ |
| K053061 | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY | Dade Behring, Inc. | 2006-02-06 | Traditional | PDF ↗ |
| K052017 | CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 | Dade Behring, Inc. | 2005-09-01 | Traditional | PDF ↗ |
| K040761 | AXSYM CYCLOSPORINE | Abbott Laboratories, Inc. | 2004-04-30 | Traditional | PDF ↗ |
| K023208 | CEDIA CYCLOSPORINE PLUS ASSAY | Microgenics Corp. | 2002-10-24 | Traditional | PDF ↗ |
| K023065 | CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2002-10-16 | Traditional | PDF ↗ |
Product code MKW · Class II · Clinical Chemistry. Data: openFDA.