PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES— 510(k) K013451
Substantially EquivalentPhoenix Diagnostics, Inc.
FDA 510(k) clearance K013451 for PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES, Substantially Equivalent on 2001-12-18. Applicant: Phoenix Diagnostics, Inc..
Clearance details
- Applicant
- Phoenix Diagnostics, Inc.
- Product code
- Code CGZ
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Natick, MA, US
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