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510(k) K063276

CLINITEK ADVANTUS, MODEL 1420 by Bayer Healthcare, LLC — Product Code JIL

K063276 is an FDA 510(k) premarket notification submitted by Bayer Healthcare, LLC for the device "CLINITEK ADVANTUS, MODEL 1420". The FDA issued a decision of Substantially Equivalent on December 28, 2006. The device falls under product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)), a Class II device regulated under 21 CFR 862.1340. Bayer Healthcare, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2006
Date Received
October 30, 2006
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

Other clearances by Bayer Healthcare, LLC

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  • K152852 — ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (December 22, 2015)
  • K150942 — Contour Next USB Blood Glucose Monitoring System (November 25, 2015)
  • K151742 — Contour Next Control Solution (September 23, 2015)
  • K130265 — CONTOUR NEXT EZ BLOOD GLUCOSE METER (June 23, 2014)
  • K122370 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR (September 26, 2013)
  • K121190 — CONTOUR NEXT BLOOD GLUCOSE METER (July 26, 2012)
  • K121087 — CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM (June 28, 2012)
  • K110894 — CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER (March 28, 2012)
  • K110587 — CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CON (March 28, 2012)

Other clearances for product code JIL

  • K193514 — AUTION MAX AX-4060 Urinalysis System (April 13, 2023)
  • K183432 — cobas u 601 urinalysis test system (May 7, 2019)
  • K173327 — DIP/U.S. Urine Analysis Test System (July 18, 2018)
  • K180356 — inui In-Home Urine Analysis Test System (May 25, 2018)
  • K181024 — DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips (May 23, 2018)
  • K171521 — DUS R-50S (Urine Chemistry system) (February 16, 2018)
  • K171083 — iChemVELOCITY Automated Urine Chemistry System (May 12, 2017)
  • 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)

FDA data resources