KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
K-Number: K220085 · 2023-08-24
ApplicantKronus, Inc.
Decision Date2023-08-24
Product CodeOIF
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is a medical device manufactured by Kronus, Inc.. It received FDA 510(k) clearance on 2023-08-24 under approval number K220085. The device is classified under product code OIF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit?
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is a medical device that received FDA 510(k) clearance on 2023-08-24. It is manufactured by Kronus, Inc.. The 510(k) number is K220085.
When was KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit approved by the FDA?
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit received FDA 510(k) clearance on 2023-08-24, under approval number K220085.
What company makes KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit?
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is manufactured by Kronus, Inc..
What is the FDA product code for KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit?
The FDA product code for KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is OIF.
Other Devices by Kronus, Inc.
Related Devices (Code: OIF)
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.