CHL · Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Clinical Chemistry · 21 CFR 862.1120 · Class 2
Overview
| Product Code | CHL |
|---|---|
| Device Name | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph |
| Regulation | 21 CFR 862.1120 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 188)
Showing 20 most recent of 188 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | Apr 10, 2026 | SESE |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | May 2, 2025 | SESE |
| K240998 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | Dec 13, 2024 | SESE |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Oct 27, 2023 | SESE |
| K221900 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | Sep 29, 2023 | SESE |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Sep 15, 2023 | SESE |
| K223608 | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company | Aug 10, 2023 | SESE |
| K211559 | EasyStat 300 | Medica Corporation | Jan 27, 2023 | SESE |
| K203790 | GEM Premier 5000 | Instrumentation Laboratory CO | Aug 20, 2021 | SESE |
| K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | Aug 2, 2021 | SESE |
| K200107 | epoc Blood Analysis System | Epocal, Inc. | Jun 5, 2020 | SESE |
| K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | Apr 9, 2020 | SESE |
| K192240 | RAPIDPoint 500e Blood Gas System | Siemens Healthcare Diagnostics, Inc. | Mar 27, 2020 | SESE |
| K193246 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | Jan 24, 2020 | SESE |
| K173797 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | Jul 17, 2018 | SESE |
| K173403 | GEM Premier 5000 | Instrumentation Laboratory CO | Dec 29, 2017 | SESE |
| K160412 | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) | Instrumentation Laboratory CO | Dec 14, 2016 | SESE |
| K160153 | ABL90 FLEX PLUS | Radiometer Medical Aps | Nov 4, 2016 | SESE |
| 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. | Jul 15, 2016 | SESE |
| K151982 | Stat Profile Prime ABG Analyzer System | Nova Biomedical Corporation | Sep 10, 2015 | SESE |
Top Applicants
- Nova Biomedical Corp. — 20 clearances
- Fisher Scientific Co., LLC — 15 clearances
- Instrumentation Laboratory CO — 15 clearances
- Radiometer America, Inc. — 15 clearances
- Radiometer Medical Aps — 13 clearances
