Product code CHL
- Device name
- Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1120
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | 2026-04-10 |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025-05-02 |
| K240998 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2024-12-13 |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-10-27 |
| K221900 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2023-09-29 |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-09-15 |
| K223608 | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company | 2023-08-10 |
| K211559 | EasyStat 300 | Medica Corporation | 2023-01-27 |
| K203790 | GEM Premier 5000 | Instrumentation Laboratory CO | 2021-08-20 |
| K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | 2021-08-02 |
| K200107 | epoc Blood Analysis System | Epocal, Inc. | 2020-06-05 |
| K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-04-09 |
| K192240 | RAPIDPoint 500e Blood Gas System | Siemens Healthcare Diagnostics, Inc. | 2020-03-27 |
| K193246 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-01-24 |
| K173797 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-07-17 |
| K173403 | GEM Premier 5000 | Instrumentation Laboratory CO | 2017-12-29 |
| K160412 | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) | Instrumentation Laboratory CO | 2016-12-14 |
| K160153 | ABL90 FLEX PLUS | Radiometer Medical Aps | 2016-11-04 |
| K151978 | EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control | Edan Instruments, Inc. | 2016-07-15 |
| K151982 | Stat Profile Prime ABG Analyzer System | Nova Biomedical Corporation | 2015-09-10 |
| K151856 | ABL80 FLEX CO-OX with AQURE connectivity | Sendx Medical, Inc. | 2015-08-06 |
| K142898 | ABL800 FLEX with AQURE connectivity | Radiometer Medical Aps | 2015-06-17 |
| K141907 | STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A | Nova Biomedical Corporation | 2015-05-29 |
| K142220 | Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) | Nova Biomedical Corporation | 2014-10-17 |
| K131703 | NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM | Nova Biomedical Corporation | 2014-03-25 |
| K133407 | GEM PREMIER 4000 | Instrumentation Laboratory CO | 2014-01-13 |
| K131988 | ABL90 FLEX ANALYZER | Radiometer Medical Aps | 2013-09-17 |
| K131126 | OPTI CCA-TS2 | Opti Medical Systems, Inc. | 2013-08-22 |
| K130144 | ABL90 FLEX | Radiometer Medical Aps | 2013-07-31 |
| K123748 | ABL90 FLEX | Radiometer Medical Aps | 2013-05-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00054749005673 | i-STAT G3+ Cartridge | Abbott Point of Care Inc. | 2023-12-18 |
| 10054749005502 | i-STAT | ABBOTT POINT OF CARE INC. | 2020-10-05 |
| 00385480118026 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-22 |
| 00385480340816 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480329651 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480322041 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480289542 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480289535 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480278072 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480278034 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480248198 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480243278 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480239622 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480230230 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480225076 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480217958 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480215206 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480215190 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480215138 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480214902 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480152150 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480150866 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480132039 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480128827 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480000185 | Nova | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480205191 | NOVA/STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480131957 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480131438 | NOVA | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480115339 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 10054749000132 | i-STAT | ABBOTT POINT OF CARE INC. | 2016-09-09 |