PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE— 510(k) K020129
Substantially EquivalentPhoenix Diagnostics, Inc.
FDA 510(k) clearance K020129 for PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE, Substantially Equivalent on 2002-02-01. 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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More clearances from Phoenix Diagnostics, Inc.
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- K013451 — PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
- K012987 — PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.