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510(k) K140717

CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT by Siemens Healthcare Diagnostics — Product Code KQO

K140717 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KIT". The FDA issued a decision of Substantially Equivalent on November 17, 2014. The device falls under product code KQO (Automated Urinalysis System), a Class I device regulated under 21 CFR 862.2900. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2014
Date Received
March 20, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Urinalysis System
Device Class
Class I
Regulation Number
862.2900
Review Panel
CH
Submission Type

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  • K242685 — Atellica® CH Creatinine_3 (Crea3) (December 4, 2024)
  • K241800 — Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (July 26, 2024)
  • K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) (July 25, 2024)

Other clearances for product code KQO

  • K141874 — URISCAN OPTIMA (May 28, 2015)
  • K142543 — Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid (May 11, 2015)
  • K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET (February 1, 2013)
  • K102188 — CYBOW READER, MODELS 300 & 720 (August 9, 2011)
  • K101852 — CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT (March 23, 2011)
  • K091472 — URITEST 50 AND URITEST 500 URINE ANALYZER (April 27, 2010)
  • K093555 — COBAS U411 TEST SYSTEM (April 2, 2010)
  • K093098 — AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (December 23, 2009)
  • K070929 — ACON U120 URINE ANALYZER, MODEL U111-101 (July 30, 2007)
  • K053253 — HEMOCUE ALBUMIN 201 ANALYZING SYSTEM (February 17, 2006)

FDA data resources