Radiometer Acid Base LABORATORY-ABL-3
FDA 510(k) K800224 · The London Co.
510(k) numberK800224
Submission
- Device name
- Radiometer Acid Base LABORATORY-ABL-3
- Applicant
- The London Co.
Mchenry, IL, US - Received
- February 5, 1980
- Decision date
- February 22, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBESCHL · Traditional | Radiometer Medicals Aps | 04/10/2026SE |
| 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 |
|---|---|---|
| K802846 | TCM202 TCPO2 & TCM204 TCPO2/PO2 Rec. Sy.KLK · Traditional | 12/17/1980SE |
| K801848 | ICA1 Ionized Calcium AnalyzerJFP · Traditional | 10/31/1980SE |
| K780652 | Hemoglobin Check Solutions, S2100 OSM-2JKS · Traditional | 07/27/1978SE |
| K771444 | Qualicheck TMJJS · Traditional | 08/16/1977SE |
| K771263 | Radiomhter OSM-2 HemoximeterGHS · Traditional | 08/03/1977SE |
| K760229 | Acid Base System, Radiometer AutomatedCHL · Traditional | 08/26/1976SE |
Questions and answers
When was Radiometer Acid Base LABORATORY-ABL-3 cleared by the FDA?
Radiometer Acid Base LABORATORY-ABL-3 (K800224) received a 510(k) decision of Substantially Equivalent on February 22, 1980, 17 days after the submission was received.
What is the product code of K800224?
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.