ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2— 510(k) K111996
Substantially EquivalentElitechgroup
FDA 510(k) clearance K111996 for ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2, Substantially Equivalent on 2011-09-14. Applicant: Elitechgroup. Device class: 1.
Clearance details
- Applicant
- Elitechgroup
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Bothell, WA, US
Recent devices under product code JJY
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- K163629 — Audit MicroControls Linearity FD Tumor Markers II
- K163015 — Liquichek Tumor Marker Control-Level 1 +3 more
- K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
- K150300 — Liquichek Cardiac Markers Plus Control LT
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
- K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
Data sourced from openFDA. This site is unofficial and independent of the FDA.