ABL700 Series Blood Gas , Co-Oximetry, Electrolyte & Metabolite System
FDA 510(k) K980130 · Radiometer America, Inc.
510(k) numberK980130
Submission
- Device name
- ABL700 Series Blood Gas , Co-Oximetry, Electrolyte & Metabolite System
- Applicant
- Radiometer America, Inc.
Westlake, OH, US - Received
- January 14, 1998
- Decision date
- February 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 05/02/2025SE |
| K240998 | ABL90 FLEX PLUS SystemCHL · Traditional | Radiometer Medicals Aps | 12/13/2024SE |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 10/27/2023SE |
| K221900 | Stat Profile Prime Plus Analyzer SystemCHL · Traditional | Nova Biomedical Corporation | 09/29/2023SE |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 SystemCHL · Traditional | Abbott Point of Care, Inc. | 09/15/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | Instrumentation Laboratory Company | 08/10/2023SE |
| K211559 | EasyStat 300CHL · Traditional | Medica Corporation | 01/27/2023SE |
| K203790 | GEM Premier 5000CHL · Special | Instrumentation Laboratory CO | 08/20/2021SE |
| K200986 | OPTI® B-Lac CassetteCHL · Traditional | Opti Medical Systems, Inc. | 08/02/2021SE |
More from Opti Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | 01/28/2016SE |
| K992859 | ABL700 Series Analyzer with Autocheck ModuleCHL · Special | 01/10/2000SE |
| K991417 | Abl 735 AnalyzerCHL · Traditional | 11/24/1999SE |
| K982928 | NPT7 Series Ph/Blood Gas and Co-Oximetry SystemCHL · Traditional | 01/06/1999SE |
| K980135 | QUALICHECK5+ Models S7730, S7740, S7750, S7760JJS · Traditional | 01/28/1998SE |
| K974818 | ABL555 Blood Gas, Electrolyte & Metabolite SystemMMI · Traditional | 01/16/1998SE |
| K973367 | ABL555 Blood Gas, Electrolyte & Metabolite SystemCHL · Traditional | 10/06/1997SE |
| K962158 | Pico Models 30, 50, 70JKA · Traditional | 10/29/1996SE |
| K962334 | EML105 Electrolyte Metabolite AnalyzerJGS · Traditional | 10/24/1996SE |
| K961355 | MulticheckJJS · Traditional | 06/14/1996SE |
Questions and answers
When was ABL700 Series Blood Gas , Co-Oximetry, Electrolyte & Metabolite System cleared by the FDA?
ABL700 Series Blood Gas , Co-Oximetry, Electrolyte & Metabolite System (K980130) received a 510(k) decision of Substantially Equivalent on February 9, 1998, 26 days after the submission was received.
What is the product code of K980130?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.