IDS-iSYS Ostase BAP
K-Number: K200475 · 2020-09-30
ApplicantImmunodiagnostic Systems , Ltd.
Decision Date2020-09-30
Product CodeCIN
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
IDS-iSYS Ostase BAP is a medical device manufactured by Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2020-09-30 under approval number K200475. The device is classified under product code CIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IDS-iSYS Ostase BAP?
IDS-iSYS Ostase BAP is a medical device that received FDA 510(k) clearance on 2020-09-30. It is manufactured by Immunodiagnostic Systems , Ltd.. The 510(k) number is K200475.
When was IDS-iSYS Ostase BAP approved by the FDA?
IDS-iSYS Ostase BAP received FDA 510(k) clearance on 2020-09-30, under approval number K200475.
What company makes IDS-iSYS Ostase BAP?
IDS-iSYS Ostase BAP is manufactured by Immunodiagnostic Systems , Ltd..
What is the FDA product code for IDS-iSYS Ostase BAP?
The FDA product code for IDS-iSYS Ostase BAP is CIN.
Other Devices by Immunodiagnostic Systems , Ltd.
Related Devices (Code: CIN)
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.