Radiometer Medical Aps

• CHL — Clinical Chemistry13 devices
• JJS — Clinical Chemistry3 devices
• JHX — Clinical Chemistry2 devices
• LKD — Anesthesiology2 devices
• MQM — Clinical Chemistry2 devices
• CEM — Clinical Chemistry1 device
• CGL — Clinical Chemistry1 device
• CIG — Clinical Chemistry1 device
• JJY — Clinical Chemistry1 device
• JKA — Clinical Chemistry1 device

• Z-1659-2025 — Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiometer ABL90 Series - Radiometer ABL90 FLEX PLUS Model Number 393-092 The Radiometer ABL90 Series is a portable, automated analyzer for use in the laboratory environment, near patients or point-of-care settings.Class II·Ongoing·2025-03-21
• Z-2426-2024 — ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.Class II·Ongoing·2024-05-31
• Z-1394-2023 — AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.Class II·Ongoing·2023-03-08
• Z-1321-2022 — ABL800 Flex Analyzer Model Numbers 393-800 and 393-801Class II·Ongoing·2022-05-18
• Z-1115-2022 — Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CEClass II·Ongoing·2022-04-08
• Z-1858-2021 — E3800 PC Units (spare parts)Class II·Ongoing·2021-04-14
• Z-1857-2021 — Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.Class II·Ongoing·2021-04-14
• Z-1856-2021 — Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.Class II·Ongoing·2021-04-14
• Z-1683-2021 — PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518 PICO70 w/o needle; 956-519 PICO70 w/o needle; 956-522 PICO70 22G x 25 mm; 956-525 PICO70 22G x 32 mm; 956-529 PICO70 23G x 16 mm; 956-533 PICO70 23G x 25 mm; 956-534 PICO70 23G x 32 mm; 956-547 PICO70 25G x 16 mm;Class II·Terminated·2021-03-26
• Z-2494-2020 — Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-801; UDI (01)05700693938011. Model 393-801 is available as ABL837. The FlexQ module is optional and can be added to all models and configurations.Class II·Terminated·2020-05-26

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXCode JHX·2017-09-21
• K170882 — ABL90 FLEX, ABL90 FLEX PLUSCode MQM·2017-04-28
• K160153 — ABL90 FLEX PLUSCode CHL·2016-11-04
• K142898 — ABL800 FLEX with AQURE connectivityCode CHL·2015-06-17
• K150226 — Hematocrit and Metabolite QUALICHECKCode JJS·2015-05-13
• K132691 — ABL90 FLEXCode MQM·2014-11-13
• K131988 — ABL90 FLEX ANALYZERCode CHL·2013-09-17
• K130144 — ABL90 FLEXCode CHL·2013-07-31
• K123748 — ABL90 FLEXCode CHL·2013-05-07
• K130415 — HIGH METABOLITE QUALICHECKCode JJS·2013-03-26
• K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3Code JJS·2013-03-15
• K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGECode JHX·2012-11-21
• K122729 — ABL90 FLEXCode CHL·2012-11-16
• K122642 — ABL90 FLEXCode CHL·2012-10-26
• K120197 — ABL90 FLEXCode CHL·2012-03-19
• K112161 — AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..Code KHO·2012-01-20
• K111897 — ABL90Code CHL·2011-07-19
• K110416 — ABL835 FLEX ANALYZER WITH PLEURAL PHCode CHL·2011-03-24
• K100777 — ABL837 FLEX ANALYZERCode CHL·2010-12-10
• K092686 — ABL90 FLEX SERIESCode CEM·2010-08-06
• K093154 — TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEMCode LKD·2010-02-05
• K051968 — ABL8X7 FLEXCode CGL·2006-10-16
• K051928 — AUTOCHECK6+Code JJY·2005-10-12
• K050869 — MODIFICATION TO ABL800 FLEXCode CIG·2005-08-11
• K043218 — ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XXCode CHL·2005-05-10
• K043143 — SAFEPICOCode JKA·2005-04-22
• K043003 — TCM40 MONITORING SYSTEMCode LKD·2005-03-01
• K041874 — ABL800 FLEXCode CHL·2004-10-08