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510(k) K122177

ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL by Elitechgroup — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2013
Date Received
July 23, 2012
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K163544 — Lumipulse G Prolactin (January 12, 2017)
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