IDS ACTH II
K-Number: K223867 · 2023-08-18
ApplicantImmunodiagnostic Systems Limited
Decision Date2023-08-18
Product CodeCKG
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
IDS ACTH II is a medical device manufactured by Immunodiagnostic Systems Limited. It received FDA 510(k) clearance on 2023-08-18 under approval number K223867. The device is classified under product code CKG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IDS ACTH II?
IDS ACTH II is a medical device that received FDA 510(k) clearance on 2023-08-18. It is manufactured by Immunodiagnostic Systems Limited. The 510(k) number is K223867.
When was IDS ACTH II approved by the FDA?
IDS ACTH II received FDA 510(k) clearance on 2023-08-18, under approval number K223867.
What company makes IDS ACTH II?
IDS ACTH II is manufactured by Immunodiagnostic Systems Limited.
What is the FDA product code for IDS ACTH II?
The FDA product code for IDS ACTH II is CKG.
Other Devices by Immunodiagnostic Systems Limited
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.