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.. 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
Recent devices under product code CGZ
view all- K182072 — VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
- K170320 — Alinity c ICT Sample Diluent
- K162020 — VITROS Chemistry Products Cl- Slides
- K082099 — VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905
- K070889 — AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112
More clearances from Phoenix Diagnostics, Inc.
view all- K023268 — PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
- K020364 — PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
- K020148 — pHoenix ISE Reagents FOR Olympus AU Chemistry Systems
- K020129 — PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
- K012987 — PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.