PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES— 510(k) K013451

Substantially Equivalent

Phoenix 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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