ABL800 Flex with Flexq Module, Model ABL8XX
FDA 510(k) K043218 · Radiometer Medical Aps
510(k) numberK043218
Submission
- Device name
- ABL800 Flex with Flexq Module, Model ABL8XX
- Applicant
- Radiometer Medical Aps
Bronshoj, DK - Received
- November 22, 2004
- Decision date
- May 10, 2005
- 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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More from Opti Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXJHX · Traditional | 09/21/2017SE |
| K170882 | ABL90 Flex, ABL90 Flex PlusMQM · Traditional | 04/28/2017SE |
| K160153 | ABL90 Flex PlusCHL · Special | 11/04/2016SE |
| K142898 | ABL800 FLEX with AQURE connectivityCHL · Special | 06/17/2015SE |
| K150226 | Hematocrit and Metabolite QUALICHECKJJS · Traditional | 05/13/2015SE |
| K132691 | ABL90 FlexMQM · Traditional | 11/13/2014SE |
| K131988 | ABL90 Flex AnalyzerCHL · Traditional | 09/17/2013SE |
| K130144 | ABL90 FlexCHL · Special | 07/31/2013SE |
| K123748 | ABL90 FlexCHL · Special | 05/07/2013SE |
| K130415 | High Metabolite QualicheckJJS · Traditional | 03/26/2013SE |
Questions and answers
When was ABL800 Flex with Flexq Module, Model ABL8XX cleared by the FDA?
ABL800 Flex with Flexq Module, Model ABL8XX (K043218) received a 510(k) decision of Substantially Equivalent on May 10, 2005, 169 days after the submission was received.
What is the product code of K043218?
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.