FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇰 Denmark
ABL90 FLEX, ABL90 FLEX PLUS
K Number: K170882
·
Decision Apr 28, 2017
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
16
Applicant Total
28
Review Days
35
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
- ABL90 FLEX, ABL90 FLEX PLUS
- K Number
- K170882
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1113
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiometer Medical Aps
- Date Received
- March 24, 2017
- Decision Date
- April 28, 2017
- Product Code
- MQM
- 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 |
|---|---|---|---|
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQM), ordered by most recent decision date.
DRAEGER JAUNDICE METER JM-105
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ABL90 FLEX
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RAPIDPOINT 405 NEONATAL BILIRUBIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
FDA 510(k)
FDA Class 1
·Clinical Chemistry
JAUNDICE METER, MODEL JM 103
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
FDA 510(k)
FDA Class 1
·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 |
| 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 |
| K130236 | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 | Mar 15, 2013 | Substantially Equivalent |