Atlas FDA

ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS

FDA 510(k) clearance K111960 · decided 2011-11-18

Clearance details

K-number
K111960
Device name
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS
Applicant
Elitechgroup
Decision
Substantially Equivalent
Date received
2011-07-11
Decision date
2011-11-18
Days to decision
130 days
Clearance type
Traditional
Product code
KHS
Device class
2
Regulation number
862.1160
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

No recalls on record reference this clearance.