FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
K Number: K043218
·
Decision May 10, 2005
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
187
Applicant Total
28
Review Days
169
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
- K Number
- K043218
- 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
- November 22, 2004
- Decision Date
- May 10, 2005
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CHL), ordered by most recent decision date.
ABL90 FLEX PLUS System, safeCLINITUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CG4+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABL90 FLEX PLUS System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CG8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Stat Profile Prime Plus Analyzer System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT G3+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |
| K131988 | ABL90 FLEX ANALYZER | Sep 17, 2013 | 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 |