pHoenix ISE Reagents FOR Olympus AU Chemistry Systems— 510(k) K020148
Substantially EquivalentPhoenix Diagnostics, Inc.
FDA 510(k) clearance K020148 for pHoenix ISE Reagents FOR Olympus AU Chemistry Systems, Substantially Equivalent on 2002-02-04. Applicant: Phoenix Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Phoenix Diagnostics, Inc.
- Product code
- Code CGZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1170
- 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.