ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1— 510(k) K171401
Substantially EquivalentElitechgroup
FDA 510(k) clearance K171401 for ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1, Substantially Equivalent on 2017-07-11. Applicant: Elitechgroup. Device class: 2.
Clearance details
- Applicant
- Elitechgroup
- Product code
- Code CIG
- Device class
- Class 2
- Regulation
- 21 CFR 862.1110
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sees, FR
Recent devices under product code CIG
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- 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
- K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
- K141265 — ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.