MKW
9 FDA 510(k) clearances · Product code
36 daysmedian time to decision
475 days90th percentile
9clearances measured
FDA profile
- Official device name
- Cyclosporine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1235
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2002: 2 · 2011: 108 · 2012: 36 · 2013: 30
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CYCLOSPORINE (K080751) | Fujirebio Diagnostics,Inc. | 2008-09-11 |
| ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR (K071455) | Siemens Medical Solutions Diagnostics | 2008-09-11 |
| DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 (K081992) | Siemens Healthcare Diagnostics, Inc. | 2008-08-05 |
| DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (K062236) | Dade Behring, Inc. | 2006-08-21 |
| EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY (K053061) | Dade Behring, Inc. | 2006-02-06 |
| CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 (K052017) | Dade Behring, Inc. | 2005-09-01 |
| AXSYM CYCLOSPORINE (K040761) | Abbott Laboratories, Inc. | 2004-04-30 |
| CEDIA CYCLOSPORINE PLUS ASSAY (K023208) | Microgenics Corp. | 2002-10-24 |
| CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE (K023065) | Dade Behring, Inc. | 2002-10-16 |
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Every clearance here is in the API, with alerts when new ones post.