Atlas FDA

ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH

FDA 510(k) clearance K110830 · decided 2011-06-21

Clearance details

K-number
K110830
Device name
ELITECH CLINICAL SYSTEMS CALCIUM ARSENAZO; ELITECH CLINICAL SYSTEMS ALBUMIN; ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH
Applicant
Elitechgroup
Decision
Substantially Equivalent
Date received
2011-03-25
Decision date
2011-06-21
Days to decision
88 days
Clearance type
Traditional
Product code
CIX
Device class
2
Regulation number
862.1035
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Bothell, WA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human recall (Z-0178-2014)SEPPIM SAS2013-11-07