MULTI ANALYTE MIXTURE, CALIBRATORS— 510(k) K902675
Substantially EquivalentPhoenix Diagnostics, Inc.
FDA 510(k) clearance K902675 for MULTI ANALYTE MIXTURE, CALIBRATORS, Substantially Equivalent on 1990-07-31. Applicant: Phoenix Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Phoenix Diagnostics, Inc.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Medfield, MA, US
Recent devices under product code JIX
view all- K161140 — VITROS Chemistry Products Calibrator Kit 3
- K153365 — ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
- K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
- K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
- K141388 — SYSTEM CALIBRATER
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
- K013451 — PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.