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510(k) K051968

ABL8X7 FLEX by Radiometer Medical Aps — Product Code CGL

K051968 is an FDA 510(k) premarket notification submitted by Radiometer Medical Aps for the device "ABL8X7 FLEX". The FDA issued a decision of Substantially Equivalent on October 16, 2006. The device falls under product code CGL (Electrode, Ion Based, Enzymatic, Creatinine), a Class II device regulated under 21 CFR 862.1225. Radiometer Medical Aps has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2006
Date Received
July 20, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Based, Enzymatic, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Radiometer Medical Aps

  • K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (September 21, 2017)
  • K170882 — ABL90 FLEX, ABL90 FLEX PLUS (April 28, 2017)
  • K160153 — ABL90 FLEX PLUS (November 4, 2016)
  • K142898 — ABL800 FLEX with AQURE connectivity (June 17, 2015)
  • K150226 — Hematocrit and Metabolite QUALICHECK (May 13, 2015)
  • K132691 — ABL90 FLEX (November 13, 2014)
  • K131988 — ABL90 FLEX ANALYZER (September 17, 2013)
  • K130144 — ABL90 FLEX (July 31, 2013)
  • K123748 — ABL90 FLEX (May 7, 2013)
  • K130415 — HIGH METABOLITE QUALICHECK (March 26, 2013)

Other clearances for product code CGL

  • K261039 — i-STAT Crea cartridge with the i-STAT 1 System (June 26, 2026)
  • K171059 — Nova StatSensor Creatinine Hospital Meter System (May 26, 2017)
  • K113726 — EPOC CHLORIDE TEST AND EPOC CREATININE TEST (October 5, 2012)
  • K070068 — NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS (May 7, 2007)
  • K991727 — STAT PROFILE M7 ANALYZER (July 16, 1999)
  • K973292 — I-STAT SYSTEM (October 20, 1997)
  • K903034 — RENALYZER PRX 90 (March 13, 1991)

FDA data resources