DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108— 510(k) K081992
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K081992 for DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108, Substantially Equivalent on 2008-08-05. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code MKW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1235
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Newark, DE, US
Recent devices under product code MKW
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.