Home / 510(k) Clearances / K200811

510(k) K200811

cobas u 701 microscopy analyzer by Roche Diagnostics — Product Code LKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2020
Date Received
March 27, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Urine Particle
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type

Other clearances by Roche Diagnostics

  • K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (February 12, 2026)
  • K253491 — ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; (February 12, 2026)
  • K253839 — Elecsys Anti-SARS-CoV-2 (December 17, 2025)
  • K253188 — CoaguChek XS Plus System (October 24, 2025)
  • K252163 — Elecsys Phospho-Tau (181P) Plasma (October 8, 2025)
  • K242505 — Elecsys Cortisol III (July 17, 2025)
  • K250768 — Elecsys Anti-SARS-CoV-2 (June 10, 2025)
  • K241453 — Elecsys sFlt-1 and Elecsys PlGF (February 7, 2025)
  • K233060 — Elecsys Folate III (June 17, 2024)
  • K220272 — cobas pulse blood glucose monitoring system (April 26, 2024)

Other clearances for product code LKM

  • K252580 — iQ200 Series (September 10, 2025)
  • K232416 — AUTION EYE AI-4510 Urine Particle Analysis System (May 3, 2024)
  • K210127 — iQ200 System, iChemVELOCITY Automated Urine Chemistry System (July 2, 2021)
  • K171883 — Sysmex UF-5000 Fully Automated Urine Particle Analyzer (April 23, 2018)
  • K093861 — IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE (February 5, 2010)
  • K083002 — SYSMEX UF-500I AUTOMATED URINE PARTICLE ANALYZER (February 3, 2009)
  • K080887 — SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE (May 2, 2008)
  • K070910 — SYSMEX MODEL UF1000I (May 25, 2007)
  • K053135 — SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER (January 4, 2006)
  • K022774 — IQ 200 SYSTEM (October 21, 2002)