Submission Details
| 510(k) Number | K062236 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 02, 2006 |
| Decision Date | August 21, 2006 |
| Days to Decision | 19 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Special
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
Aug 2006
Decision
19d
Days
Class 2
Risk
About This 510(k) Submission
K062236 is an FDA 510(k) clearance for the DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE, a Cyclosporine (Class II — Special Controls, product code MKW), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on August 21, 2006, 19 days after receiving the submission on August 2, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1235.
Device Classification
| Product Code | MKW — Cyclosporine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1235 |
Manufacturer
Similar Devices — MKW Cyclosporine
All 8
K071455 · Siemens Medical Solutions Diagnostics
· Sep 2008
K080751 · Fujirebio Diagnostics,Inc.
· Sep 2008
K081992 · Siemens Healthcare Diagnostics, Inc.
· Aug 2008
K053061 · Dade Behring, Inc.
· Feb 2006
K052017 · Dade Behring, Inc.
· Sep 2005
K040761 · Abbott Laboratories, Inc.
· Apr 2004
More from Dade Behring, Inc.
View all
K093848
· GGN · Dec 2010
K081161
· CFN · Jul 2008
K081249
· DEB · Jul 2008
K071603
· DHX · Jun 2008
K071597
· LOJ · Jun 2008