DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)— 510(k) K123677
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K123677 for DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL), Substantially Equivalent on 2013-03-07. Applicant: Siemens Healthcare Diagnostics. Device class: 1.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code JIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.1065
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newark, DE, US
Recent devices under product code JIF
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Recalls naming K123677
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123677.
Data sourced from openFDA. This site is unofficial and independent of the FDA.