PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS— 510(k) K023268
Substantially EquivalentPhoenix Diagnostics, Inc.
FDA 510(k) clearance K023268 for PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS, Substantially Equivalent on 2002-11-15. 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.