ABL90 Flex, ABL90 Flex Plus
FDA 510(k) K170882 · Radiometer Medical Aps
510(k) numberK170882
Submission
- Device name
- ABL90 Flex, ABL90 Flex Plus
- Applicant
- Radiometer Medical Aps
Broenshoej, DK - Received
- March 24, 2017
- Decision date
- April 28, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQM – Bilirubin (Total And Unbound) In The Neonate Test System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1113
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MQM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K133175 | Draeger Jaundice Meter JM-105MQM · Traditional | Draeger Medical Systems, Inc. | 11/13/2014SE |
| K132691 | ABL90 FlexMQM · Traditional | Radiometer Medical Aps | 11/13/2014SE |
| K110277 | Rapidpoint 405 Neonatal BilirubinMQM · Traditional | Siemens Healthcare Diagnostics | 08/15/2011SE |
| K073537 | Neonatal Bilirubin on Rapidlab Models 1245 and 1265MQM · Traditional | Siemens Medical Solutions Diagnostics | 06/27/2008SE |
| K042522 | Jaundice Meter, Model JM 103MQM · Traditional | Draeger Medical Infant Care, Inc. | 07/06/2005SE |
| K040174 | Bilirubin Assay on the Omni S AnalyzerMQM · Traditional | Roche Diagnostics Corp. | 05/14/2004SE |
| K021622 | Hill-Rom Air Shields/Minolta Jaundice Meter, Model JM-103MQM · Traditional | Hill-Rom Air-Shields | 04/01/2003SE |
| K001687 | Colormate TLC Bilitest SystemMQM · Traditional | Chromatics Color Sciences Intl., Inc. | 09/13/2001SE |
| K010052 | Respironics Bilichek NON-INVASIVE-100-0800-20; Bilirubin AnalyzerMQM · Abbreviated | Respironics, Inc. | 03/19/2001SE |
| K994438 | Bilichek Non-Invasive Bilirubin AnalyzerMQM · Traditional | Spectrx, Inc. | 02/04/2000SE |
More from Spectrx, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXJHX · Traditional | 09/21/2017SE |
| 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 |
| K130236 | Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3JJS · Traditional | 03/15/2013SE |
Questions and answers
When was ABL90 Flex, ABL90 Flex Plus cleared by the FDA?
ABL90 Flex, ABL90 Flex Plus (K170882) received a 510(k) decision of Substantially Equivalent on April 28, 2017, 35 days after the submission was received.
What is the product code of K170882?
The FDA product code is MQM – Bilirubin (Total And Unbound) In The Neonate Test System, a Class I (low risk) device regulated under 21 CFR 862.1113.