ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II— 510(k) K151552
Substantially EquivalentElitechgroup
FDA 510(k) clearance K151552 for ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II, Substantially Equivalent on 2015-07-08. Applicant: Elitechgroup. Device class: 2.
Clearance details
- Applicant
- Elitechgroup
- 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
- Abbreviated
- Location
- Sees, FR
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
- K140790 — Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
- K141388 — SYSTEM CALIBRATER
- K133330 — C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
More clearances from Elitechgroup
view all- K180559 — HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
- K171401 — ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
- K153644 — ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II
- K151113 — ELITech Clinical Systems CALCIUM ARSENAZO
- K141265 — ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.