PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER— 510(k) K012987
Substantially EquivalentPhoenix Diagnostics, Inc.
FDA 510(k) clearance K012987 for PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER, Substantially Equivalent on 2001-11-07. Applicant: Phoenix Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Phoenix Diagnostics, Inc.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Natick, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.