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)
Top companies in CHL
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2024 | Radiometer 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 |
CHL | K041874 |
| Jun 26, 2024 | Siemens 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 |
CHL | K192240 |
| Dec 21, 2023 | Siemens 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 |
CHL | K200107 |
| Nov 21, 2023 | Instrumentation Laboratory GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009 Open, Classified |
CHL | K161818 K992834 |
| Nov 21, 2023 | Instrumentation Laboratory GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007 Open, Classified |
CHL | K161818 K992834 |
| Nov 21, 2023 | Instrumentation Laboratory GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004 Open, Classified |
CHL | K161818 K992834 |
| Aug 28, 2023 | Siemens 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 |
CHL | K200107 |
| Aug 28, 2023 | Siemens 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 |
CHL | K200107 |
| Aug 28, 2023 | Siemens 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 |
CHL | K200107 |
| Mar 3, 2023 | Siemens 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 |
CHL | K200107 |
| Mar 3, 2023 | Siemens 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 |
CHL | K061597 |
| Jun 1, 2022 | Siemens 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 |
CHL | K192240 |
| May 18, 2022 | Radiometer Medical ApS ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 Open, Classified |
CHL | K041874 |
| Apr 14, 2021 | Radiometer Medical ApS Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units.
The E3800 CPU is also used as spare part. Open, Classified |
CHL | K160153 |
| Dec 22, 2020 | Abbott 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 |
CHL | K940918 |
| Dec 22, 2020 | Abbott 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 |
CHL | K940918 |
| May 27, 2020 | Siemens Healthcare Diagnostics Inc RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778 Terminated |
CHL | K192240 |
| May 26, 2020 | Radiometer 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 |
CHL | K041874 |
| May 26, 2020 | Radiometer 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 |
CHL | K041874 |
| May 11, 2020 | Radiometer 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 |
CHL | K080370 |
| May 11, 2020 | Radiometer 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 |
CHL | K051804 |
| Mar 10, 2020 | Radiometer 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 |
CHL | K041874 |
| Mar 6, 2020 | Radiometer Medical ApS ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 Open, Classified |
CHL | K041874 |
| Feb 18, 2020 | Abbott 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 |
CHL | None listed |
| Feb 3, 2020 | Radiometer 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 |
CHL | K160153 |
| Nov 21, 2019 | Radiometer 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 |
CHL | K092686 |
| Nov 21, 2019 | Radiometer 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 |
CHL | K160153 |
| Sep 13, 2018 | Abbott 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 |
CHL | K940918 |
| Jul 3, 2018 | Radiometer America Inc ABL800 analyzer, model numbers 393-800 and 393-801. Terminated |
CHL | K041874 |
| Jul 2, 2018 | Radiometer 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 |
CHL | K051968 |
| Mar 14, 2018 | Radiometer 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 |
CHL | K130144 K142898 +1 |
| Oct 24, 2017 | Radiometer 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 |
CHL | K041874 |
| Jun 19, 2017 | Nova 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 |
CHL | K131703 K141907 +2 |
| Apr 10, 2017 | Siemens 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 |
CHL | K031560 K113216 |
| Jan 26, 2017 | Radiometer America Inc The ABL800 Model#:All Terminated |
CHL | K041874 |
| Jan 26, 2017 | Radiometer 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 |
CHL | K092686 |
| Jan 23, 2017 | Roche 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 |
CHL | K111188 |
| Dec 22, 2016 | Radiometer 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 |
CHL | K130144 K142898 +1 |
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc RAPIDLab 1265 Blood Gas Analyzer
Siemens Material Number (SMN):
10321852, 10470366, 10491395 Terminated |
CHL | K073537 |
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc RAPIDLab 1260 Blood Gas Analyzer
Siemens Material Number (SMN):
10321846, 10491394 Terminated |
CHL | K073537 |
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc RAPIDLab 1245 Blood Gas Analyzer
Siemens Material Number (SMN):
10321844, 10337179, 10491393 Terminated |
CHL | K031560 |
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc Siemens RAPIDLab 1240 Blood Gas Analyzer
Siemens Material Number (SMN):
10321840, 10491392 Terminated |
CHL | K031560 |
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 500 Blood Gas Analyzer
Siemens Material Number (SMN):
10492730, 10696855, 10696857, 10697306 Terminated |
CHL | K113216 |
| Aug 11, 2016 | Siemens 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 |
CHL | K110277 |
| Aug 11, 2016 | Siemens Healthcare Diagnostics Inc Siemens RAPIDPoint 400 Blood Gas Analyzer
Siemens Material Number (SMN):
10291507,10314585, 10318899,10321239,10322654,10324081,
10328803, 10331381 , 10339634 Terminated |
CHL | K002738 |
| Feb 3, 2016 | Radiometer America Inc AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers. Terminated |
CHL | K130144 K142898 +1 |
| Oct 23, 2015 | LifeHealth, 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 |
CHL | K945240 |
| Oct 23, 2015 | LifeHealth, 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 |
CHL | K945240 |
| Aug 21, 2015 | Roche 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 |
CHL | K111188 |
| Aug 21, 2015 | Roche 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 |
CHL | K111188 |
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