KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
K-Number: K161951 · 2016-07-22
ApplicantKronus, Inc.
Decision Date2016-07-22
Product CodePNI
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is a medical device manufactured by Kronus, Inc.. It received FDA 510(k) clearance on 2016-07-22 under approval number K161951. The device is classified under product code PNI. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay?
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is a medical device that received FDA 510(k) clearance on 2016-07-22. It is manufactured by Kronus, Inc.. The 510(k) number is K161951.
When was KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay approved by the FDA?
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay received FDA 510(k) clearance on 2016-07-22, under approval number K161951.
What company makes KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay?
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is manufactured by Kronus, Inc..
What is the FDA product code for KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay?
The FDA product code for KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay is PNI.
Other Devices by Kronus, Inc.
Related Devices (Code: PNI)
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.