CAPI 3 Immunotyping, Capillarys 3 Tera
K-Number: K192095 · 2019-11-01
ApplicantSebia
Decision Date2019-11-01
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
CAPI 3 Immunotyping, Capillarys 3 Tera is a medical device manufactured by Sebia. It received FDA 510(k) clearance on 2019-11-01 under approval number K192095. The device is classified under product code CFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CAPI 3 Immunotyping, Capillarys 3 Tera?
CAPI 3 Immunotyping, Capillarys 3 Tera is a medical device that received FDA 510(k) clearance on 2019-11-01. It is manufactured by Sebia. The 510(k) number is K192095.
When was CAPI 3 Immunotyping, Capillarys 3 Tera approved by the FDA?
CAPI 3 Immunotyping, Capillarys 3 Tera received FDA 510(k) clearance on 2019-11-01, under approval number K192095.
What company makes CAPI 3 Immunotyping, Capillarys 3 Tera?
CAPI 3 Immunotyping, Capillarys 3 Tera is manufactured by Sebia.
What is the FDA product code for CAPI 3 Immunotyping, Capillarys 3 Tera?
The FDA product code for CAPI 3 Immunotyping, Capillarys 3 Tera is CFF.
Other Devices by Sebia
Related Devices (Code: CFF)
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.