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510(k) K160062

AUTION ELEVEN Semi-Automated Urinalysis System by Arkray, Inc. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2016
Date Received
January 12, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

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  • K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (July 24, 2015)
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