LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)— 510(k) K133512
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K133512 for LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL), Substantially Equivalent on 2014-01-02. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Product code CDD
- Device class
- Class 2
- Regulation
- 21 CFR 862.1810
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.