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Panels › Clinical Chemistry › Product code CHL · Class 2

Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

Regulation 862.1120

1510(k)s in 12 months (188 all time)
33recalls in 12 months (185 all time)
173recalls that name a 510(k)
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Top companies in CHL

DateFirm and productCodeLinked 510(k)
Jul 24, 2024Radiometer Medical ApS
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,
Open, Classified
CHLK041874
Jun 26, 2024Siemens Healthcare Diagnostics Inc
Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751 RAPIDPoint 500e Blood Gas System (China) 11416752; RAPIDPoint 500e Blood Gas System (Japan) 1141675
Open, Classified
CHLK192240
Dec 21, 2023Siemens Healthcare Diagnostics Inc
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software
Open, Classified
CHLK200107
Nov 21, 2023Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009
Open, Classified
CHLK161818
K992834
Nov 21, 2023Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Open, Classified
CHLK161818
K992834
Nov 21, 2023Instrumentation Laboratory
GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004
Open, Classified
CHLK161818
K992834
Aug 28, 2023Siemens Healthcare Diagnostics Inc
epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Open, Classified
CHLK200107
Aug 28, 2023Siemens Healthcare Diagnostics Inc
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Open, Classified
CHLK200107
Aug 28, 2023Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Open, Classified
CHLK200107
Mar 3, 2023Siemens Healthcare Diagnostics Inc
epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 1
Open, Classified
CHLK200107
Mar 3, 2023Siemens Healthcare Diagnostics Inc
epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc H
Open, Classified
CHLK061597
Jun 1, 2022Siemens Healthcare Diagnostics Inc
epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood Product Siemens
Open, Classified
CHLK192240
May 18, 2022Radiometer Medical ApS
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Open, Classified
CHLK041874
Apr 14, 2021Radiometer Medical ApS
Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.
Open, Classified
CHLK160153
Dec 22, 2020Abbott Point Of Care Inc.
Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Numb
Terminated
CHLK940918
Dec 22, 2020Abbott Point Of Care Inc.
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood Lis
Terminated
CHLK940918
May 27, 2020Siemens Healthcare Diagnostics Inc
RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778
Terminated
CHLK192240
May 26, 2020Radiometer Medical ApS
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
Terminated
CHLK041874
May 26, 2020Radiometer Medical ApS
Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825,
Terminated
CHLK041874
May 11, 2020Radiometer Medical ApS
ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Terminated
CHLK080370
May 11, 2020Radiometer Medical ApS
ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Terminated
CHLK051804
Mar 10, 2020Radiometer Medical ApS
ABL800 FLEX, model number/UDI 393-800/0570 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 (c
Terminated
CHLK041874
Mar 6, 2020Radiometer Medical ApS
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Open, Classified
CHLK041874
Feb 18, 2020Abbott Point Of Care Inc.
i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial
Terminated
CHLNone listed
Feb 3, 2020Radiometer Medical ApS
ABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Terminated
CHLK160153
Nov 21, 2019Radiometer Medical ApS
ABL90 FLEX, model no. 393-090; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is intende
Terminated
CHLK092686
Nov 21, 2019Radiometer Medical ApS
ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. It is inte
Terminated
CHLK160153
Sep 13, 2018Abbott Point Of Care Inc.
Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)
Terminated
CHLK940918
Jul 3, 2018Radiometer America Inc
ABL800 analyzer, model numbers 393-800 and 393-801.
Terminated
CHLK041874
Jul 2, 2018Radiometer America Inc
Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821,
Terminated
CHLK051968
Mar 14, 2018Radiometer Medical ApS
AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with t
Terminated
CHLK130144
K142898 +1
Oct 24, 2017Radiometer America Inc
ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters
Terminated
CHLK041874
Jun 19, 2017Nova Biomedical Corporation
Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 5
Terminated
CHLK131703
K141907 +2
Apr 10, 2017Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and
Terminated
CHLK031560
K113216
Jan 26, 2017Radiometer America Inc
The ABL800 Model#:All
Terminated
CHLK041874
Jan 26, 2017Radiometer America Inc
ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
Terminated
CHLK092686
Jan 23, 2017Roche Diagnostics Operations, Inc.
Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), m
Terminated
CHLK111188
Dec 22, 2016Radiometer America Inc
AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from
Terminated
CHLK130144
K142898 +1
Aug 11, 2016Siemens Healthcare Diagnostics Inc
RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
Terminated
CHLK073537
Aug 11, 2016Siemens Healthcare Diagnostics Inc
RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
Terminated
CHLK073537
Aug 11, 2016Siemens Healthcare Diagnostics Inc
RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
Terminated
CHLK031560
Aug 11, 2016Siemens Healthcare Diagnostics Inc
Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
Terminated
CHLK031560
Aug 11, 2016Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696857, 10697306
Terminated
CHLK113216
Aug 11, 2016Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 10314817, 1031 7193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784
Terminated
CHLK110277
Aug 11, 2016Siemens Healthcare Diagnostics Inc
Siemens RAPIDPoint 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381 , 10339634
Terminated
CHLK002738
Feb 3, 2016Radiometer America Inc
AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
Terminated
CHLK130144
K142898 +1
Oct 23, 2015LifeHealth, LLC
BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoin
Terminated
CHLK945240
Oct 23, 2015LifeHealth, LLC
CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpo
Terminated
CHLK945240
Aug 21, 2015Roche Diagnostics Operations, Inc.
cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes N
Terminated
CHLK111188
Aug 21, 2015Roche Diagnostics Operations, Inc.
cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes N
Terminated
CHLK111188

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