DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE— 510(k) K133728
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K133728 for DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE, Substantially Equivalent on 2014-01-24. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code CGX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code CGX
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.