FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
ABL90 FLEX ANALYZER
K Number: K131988
·
Decision Sep 17, 2013
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
187
Applicant Total
28
Review Days
81
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Basic Information
- Device Name
- ABL90 FLEX ANALYZER
- K Number
- K131988
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiometer Medical Aps
- Date Received
- June 28, 2013
- Decision Date
- September 17, 2013
- Product Code
- CHL
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | FDA class 2 | Clinical Chemistry |
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Other Clearances by Radiometer Medical Aps
| K Number | Device Name | ||
|---|---|---|---|
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX | Sep 21, 2017 | Substantially Equivalent |
| K170882 | ABL90 FLEX, ABL90 FLEX PLUS | Apr 28, 2017 | Substantially Equivalent |
| K160153 | ABL90 FLEX PLUS | Nov 4, 2016 | Substantially Equivalent |
| K142898 | ABL800 FLEX with AQURE connectivity | Jun 17, 2015 | Substantially Equivalent |
| K150226 | Hematocrit and Metabolite QUALICHECK | May 13, 2015 | Substantially Equivalent |
| K132691 | ABL90 FLEX | Nov 13, 2014 | Substantially Equivalent |
| K130144 | ABL90 FLEX | Jul 31, 2013 | Substantially Equivalent |
| K123748 | ABL90 FLEX | May 7, 2013 | Substantially Equivalent |
| K130415 | HIGH METABOLITE QUALICHECK | Mar 26, 2013 | Substantially Equivalent |
| K130236 | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 | Mar 15, 2013 | Substantially Equivalent |