AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
K-Number: K163462 · 2017-09-21
ApplicantRadiometer Medical Aps
Decision Date2017-09-21
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX is a medical device manufactured by Radiometer Medical Aps. It received FDA 510(k) clearance on 2017-09-21 under approval number K163462. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX?
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX is a medical device that received FDA 510(k) clearance on 2017-09-21. It is manufactured by Radiometer Medical Aps. The 510(k) number is K163462.
When was AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX approved by the FDA?
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX received FDA 510(k) clearance on 2017-09-21, under approval number K163462.
What company makes AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX?
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX is manufactured by Radiometer Medical Aps.
What is the FDA product code for AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX?
The FDA product code for AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX is JHX.
Other Devices by Radiometer Medical Aps
Related Devices (Code: JHX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.