Home / 510(k) Clearances / K140690

510(k) K140690

BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. — Product Code CDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2014
Date Received
March 19, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

  • K253049 — Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, (February 11, 2026)
  • K251601 — Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus (December 3, 2025)
  • K251853 — Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Conson (November 7, 2025)
  • K251820 — ViewMateTM Ultrasound System (September 12, 2025)
  • K251250 — ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound Syste (September 5, 2025)
  • K243767 — SV600, SV800 Ventilator (August 28, 2025)
  • K251192 — Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnos (August 22, 2025)
  • K242728 — BeneVision Central Monitoring System (July 31, 2025)
  • K250024 — TE Air Diagnostic Ultrasound System (May 30, 2025)
  • K250020 — Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9 (May 19, 2025)

Other clearances for product code CDQ

  • K203771 — Urea Nitrogen2 (May 31, 2022)
  • K110675 — EASYRA UREA NITROGEN AND CREATININE REAGENTS (April 21, 2011)
  • K073295 — UREA/BUN, SCAL, NORTROL, ABTROL (May 29, 2008)
  • K070146 — ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP (October 12, 2007)
  • K060120 — TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM (March 27, 2006)
  • K041051 — RAICHEM BUN RATE REAGENT (LIQUID) (June 30, 2004)
  • K024182 — PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS (March 3, 2003)
  • K021385 — ATAC PAK BUN REAGENT (July 12, 2002)
  • K012649 — RAICHEM BUN RATE REAGENT (October 15, 2001)
  • K012260 — WIENER LAB. UREA UV CINETICA AA (September 19, 2001)