PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS— 510(k) K020364
Substantially EquivalentPhoenix Diagnostics, Inc.
FDA 510(k) clearance K020364 for PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS, Substantially Equivalent on 2002-06-04. Applicant: Phoenix Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Phoenix Diagnostics, Inc.
- Product code
- Code JGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1665
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Natick, MA, US
Recent devices under product code JGS
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- K020129 — PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
- K013451 — PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
- K012987 — PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
Adverse events under product code JGS
product code JGS- Malfunction
- 535
- Total
- 535
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.