SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2— 510(k) K984014
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K984014 for SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2, Substantially Equivalent on 1998-12-23. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, 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
- Brea, CA, 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 Beckman Coulter, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.