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510(k) K170882

ABL90 FLEX, ABL90 FLEX PLUS by Radiometer Medical Aps — Product Code MQM

K170882 is an FDA 510(k) premarket notification submitted by Radiometer Medical Aps for the device "ABL90 FLEX, ABL90 FLEX PLUS". The FDA issued a decision of Substantially Equivalent on April 28, 2017. The device falls under product code MQM (Bilirubin (Total And Unbound) In The Neonate Test System), a Class I device regulated under 21 CFR 862.1113. Radiometer Medical Aps has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2017
Date Received
March 24, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bilirubin (Total And Unbound) In The Neonate Test System
Device Class
Class I
Regulation Number
862.1113
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)
  • 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)
  • K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL (March 15, 2013)

Other clearances for product code MQM

  • K132691 — ABL90 FLEX (November 13, 2014)
  • K133175 — DRAEGER JAUNDICE METER JM-105 (November 13, 2014)
  • K110277 — RAPIDPOINT 405 NEONATAL BILIRUBIN (August 15, 2011)
  • K073537 — NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (June 27, 2008)
  • K042522 — JAUNDICE METER, MODEL JM 103 (July 6, 2005)
  • K040174 — BILIRUBIN ASSAY ON THE OMNI S ANALYZER (May 14, 2004)
  • K021622 — HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 (April 1, 2003)
  • K001687 — COLORMATE TLC BILITEST SYSTEM (September 13, 2001)
  • K010052 — RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER (March 19, 2001)
  • K994438 — BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (February 4, 2000)

FDA data resources