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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. It received FDA 510(k) clearance on 2016-12-08 under 510(k) 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. The listed applicant is Sekisui Diagnostics P.E.I., Inc.. The 510(k) number is K163078.

When did DC-UIBC-CAL receive FDA 510(k) clearance?

DC-UIBC-CAL received FDA 510(k) clearance on 2016-12-08, under 510(k) number K163078.

Who is the listed applicant for DC-UIBC-CAL?

The FDA 510(k) record lists Sekisui Diagnostics P.E.I., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DC-UIBC-CAL?

The FDA product code for DC-UIBC-CAL is JIT.

Other records listing Sekisui Diagnostics P.E.I., Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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