CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
K-Number: K161928 · 2016-12-21
ApplicantSebia
Decision Date2016-12-21
Product CodeCFF
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL is a medical device manufactured by Sebia. It received FDA 510(k) clearance on 2016-12-21 under approval number K161928. 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, IT/IF CONTROL?
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL is a medical device that received FDA 510(k) clearance on 2016-12-21. It is manufactured by Sebia. The 510(k) number is K161928.
When was CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL approved by the FDA?
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL received FDA 510(k) clearance on 2016-12-21, under approval number K161928.
What company makes CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL?
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL is manufactured by Sebia.
What is the FDA product code for CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL?
The FDA product code for CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL 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.