Dc-Uibc-Cal

FDA 510(k) K163078 · Sekisui Diagnostics P.E.I., Inc.

Substantially Equivalent

510(k) numberK163078

Submission

Device name
Dc-Uibc-Cal
Applicant
Sekisui Diagnostics P.E.I., Inc.
Charlottetown,, CA
Received
November 3, 2016
Decision date
December 8, 2016
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JIT – Calibrator, Secondary
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Specialty
Clinical Chemistry

Other 510(k)s with product code JIT

510(k)DeviceApplicantDecision
K171168VITROS Immunodiagnostic Products Insulin CalibratorsJIT · Abbreviated Ortho Clinical Diagnostics05/16/2017SE
K170938CalSet IGF-1JIT · Traditional Roche Diagnostics04/26/2017SE
K170160Abbott ARCHITECT Free T3JIT · Traditional Abbott Laboratories02/15/2017SE
K163546Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated Fujirebio Diagnostics,Inc.01/13/2017SE
K163534Lumipulse G FSH-N CalibratorsJIT · Abbreviated Fujirebio Diagnostics,Inc.01/13/2017SE
K163544Lumipulse G ProlactinJIT · Abbreviated Fujirebio Diagnostics,Inc.01/12/2017SE
K163521Lumipulse G LH CalibratorsJIT · Abbreviated Fujirebio Diagnostics,Inc.01/12/2017SE
K163053Lumipulse G E2-III CalibratorsJIT · Abbreviated Fujirebio Diagnostics,Inc.12/01/2016SE
K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special Siemens Healthcare Diagnostics11/17/2016SE
K160113ST AIA-PACK hsE2 Calibrator SetJIT · Traditional Tosoh Bioscience, Inc.02/17/2016SE

More from Tosoh Bioscience, Inc.

510(k)DeviceDecision
K202644AcetaminophenLDP · Traditional 02/18/2022SE
K182702SEKURE Creatine Kinase AssayCGS · Traditional 04/17/2019SE
K180835SEKURE Acetaminophen L3K AssayLDP · Traditional 02/08/2019SE
K173206SEKURE HbA1c AssayPDJ · Traditional 07/12/2018SE
K111915Magnesium AssayJGJ · Traditional 12/02/2011SE

Questions and answers

When was Dc-Uibc-Cal cleared by the FDA?

Dc-Uibc-Cal (K163078) received a 510(k) decision of Substantially Equivalent on December 8, 2016, 35 days after the submission was received.

What is the product code of K163078?

The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.