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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

Company510(k)sRecalls
Instrumentation Laboratory CO1635
Radiometer America, Inc.1530
Siemens Healthcare Diagnostics241
Nova Biomedical Corp.2811
Abbott Point of Care, Inc.431
Radiometer Medical Aps1315
Fisher Scientific Co., LLC150
Avl Scientific Corp.120
Sendx Medical, Inc.47
Ciba Corning Diagnostics Corp.70
DateFirm and productCodeLinked 510(k)
Oct 15, 2026Radiometer Medical ApS
The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point
Open, Classified		 CHLK041874
Aug 6, 2026Instrumentation Laboratory
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
Open, Classified		 CHLK203790
Aug 6, 2026Instrumentation Laboratory
GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The GEM Premier 7000 with iQM3 is a portable critical care sys
Open, Classified		 CHLK223608
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Open, Classified		 CHLK203790
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Open, Classified		 CHLK203790
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Open, Classified		 CHLK203790
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Open, Classified		 CHLK203790
Jul 29, 2026Instrumentation Laboratory
Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Intelligent Quality Management 3 (iQM3) is used as the quality control (QC) and asses
Open, Classified		 CHLK223608
Jul 29, 2026Instrumentation Laboratory
GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/Catalog Number: 00000015279 Portable blood analyzer system. Affected Accessory: Bar Code Read
Open, Classified		 CHLK203790
Apr 29, 2026Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Open, Classified		 CHLK200107
Apr 29, 2026Abbott Point Of Care Inc.
i-STAT G3+ cartridge; List Number: 03P78-26;
Open, Classified		 CHLK223857
Apr 29, 2026Abbott Point Of Care Inc.
i-STAT EG6+ cartridge; List Number: 03P77-25;
Open, Classified		 CHLK940918
Apr 29, 2026Abbott Point Of Care Inc.
i-STAT EG7+ cartridge; List Number: 03P76-25;
Open, Classified		 CHLK940918
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445010 & 00055445011.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445008.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055445004.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430011.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Model No. 00055430010.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430008.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055430004.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No: 00055415011.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415010.
Open, Classified		 CHLK160412
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415008.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000; Part No. 00055415005.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055415004.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407511.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407510.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407508.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055407504.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055360011.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055360010.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK; Part No. 00055360008.
Open, Classified		 CHLK203790
Mar 10, 2026Instrumentation Laboratory
GEM Premier 5000 PAK, Part No. 00055360004.
Open, Classified		 CHLK203790
Sep 17, 2025Abbott Point Of Care Inc.
i-STAT EG6+ cartridge. List Number: 03P77-25.
Open, Classified		 CHLNone listed
Sep 17, 2025Abbott Point Of Care Inc.
i-STAT EG7+ cartridge. List Number: 03P76-25.
Open, Classified		 CHLNone listed
Sep 17, 2025Abbott Point Of Care Inc.
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Open, Classified		 CHLNone listed
Sep 17, 2025Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Open, Classified		 CHLK244014
K940918 +1
Jul 31, 2025Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Open, Classified		 CHLK002738
Apr 29, 2025Siemens Healthcare Diagnostics Inc
epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 &
Open, Classified		 CHLK200107
Apr 29, 2025Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host SW v3.41.2, epoc NXS SW v4.14.9 & 4
Open, Classified		 CHLK200107
Apr 23, 2025Radiometer Medical ApS
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 an
Open, Classified		 CHLK092686
K160153
Dec 20, 2024Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t
Open, Classified		 CHLK200107
Dec 20, 2024Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitati
Open, Classified		 CHLK200107
Dec 20, 2024Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative
Open, Classified		 CHLK200107
Dec 20, 2024Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t
Open, Classified		 CHLK200107
Dec 20, 2024Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t
Open, Classified		 CHLK200107
Dec 20, 2024Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t
Open, Classified		 CHLK200107
Dec 20, 2024Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative t
Open, Classified		 CHLK200107
Dec 20, 2024Siemens Healthcare Diagnostics, Inc.
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative te
Open, Classified		 CHLK200107
Nov 1, 2024Siemens Healthcare Diagnostics Inc
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Open, Classified		 CHLK200107

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