pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
FDA 510(k) clearance K020148 · decided 2002-02-04
Clearance details
- K-number
- K020148
- Device name
- pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
- Applicant
- Phoenix Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-01-16
- Decision date
- 2002-02-04
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- CGZ
- Device class
- 2
- Regulation number
- 862.1170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Natick, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.