DC-UIBC-CAL
K-Number: K163078 · 2016-12-08
ApplicantSekisui Diagnostics P.E.I., Inc.
Decision Date2016-12-08
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
DC-UIBC-CAL is a medical device manufactured by Sekisui Diagnostics P.E.I., Inc.. It received FDA 510(k) clearance on 2016-12-08 under approval number K163078. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DC-UIBC-CAL?
DC-UIBC-CAL is a medical device that received FDA 510(k) clearance on 2016-12-08. It is manufactured by Sekisui Diagnostics P.E.I., Inc.. The 510(k) number is K163078.
When was DC-UIBC-CAL approved by the FDA?
DC-UIBC-CAL received FDA 510(k) clearance on 2016-12-08, under approval number K163078.
What company makes DC-UIBC-CAL?
DC-UIBC-CAL is manufactured by Sekisui Diagnostics P.E.I., Inc..
What is the FDA product code for DC-UIBC-CAL?
The FDA product code for DC-UIBC-CAL is JIT.
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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.