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510(k) K171083

iChemVELOCITY Automated Urine Chemistry System by Iris Diagnostics, A Division of Iris International, Inc. — Product Code JIL

K171083 is an FDA 510(k) premarket notification submitted by Iris Diagnostics, A Division of Iris International, Inc. for the device "iChemVELOCITY Automated Urine Chemistry System". The FDA issued a decision of Substantially Equivalent on May 12, 2017. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2017
Date Received
April 11, 2017
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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  • K160062 — AUTION ELEVEN Semi-Automated Urinalysis System (October 7, 2016)
  • K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM (July 22, 2016)
  • K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS (July 24, 2015)
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FDA data resources