FDA 510(k)

IDS-iSYS Intact PTHN

K-Number: K161158 · 2017-01-31

ApplicantImmunodiagnostic Systems , Ltd.

Decision Date2017-01-31

Product CodeCEW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IDS-iSYS Intact PTHN is a medical device manufactured by Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2017-01-31 under approval number K161158. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDS-iSYS Intact PTHN?

IDS-iSYS Intact PTHN is a medical device that received FDA 510(k) clearance on 2017-01-31. It is manufactured by Immunodiagnostic Systems , Ltd.. The 510(k) number is K161158.

When was IDS-iSYS Intact PTHN approved by the FDA?

IDS-iSYS Intact PTHN received FDA 510(k) clearance on 2017-01-31, under approval number K161158.

What company makes IDS-iSYS Intact PTHN?

IDS-iSYS Intact PTHN is manufactured by Immunodiagnostic Systems , Ltd..

What is the FDA product code for IDS-iSYS Intact PTHN?

The FDA product code for IDS-iSYS Intact PTHN is CEW.

Other Devices by Immunodiagnostic Systems , Ltd.

K161831IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set K161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers K190121IDS SHBG K200475IDS-iSYS Ostase BAP K202136IDS Cortisol

Related Devices (Code: CEW)

K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc. K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc. K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical Diagnostics K231927Elecsys PTH , Elecsys PTH STATRoche Diagnostics K232791Access Intact PTHBeckman Coulter, Inc.

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.