FDA 510(k)

IDS Cortisol

K-Number: K202136 · 2021-04-13

ApplicantImmunodiagnostic Systems , Ltd.

Decision Date2021-04-13

Product CodeCGR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IDS Cortisol is a medical device manufactured by Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2021-04-13 under approval number K202136. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDS Cortisol?

IDS Cortisol is a medical device that received FDA 510(k) clearance on 2021-04-13. It is manufactured by Immunodiagnostic Systems , Ltd.. The 510(k) number is K202136.

When was IDS Cortisol approved by the FDA?

IDS Cortisol received FDA 510(k) clearance on 2021-04-13, under approval number K202136.

What company makes IDS Cortisol?

IDS Cortisol is manufactured by Immunodiagnostic Systems , Ltd..

What is the FDA product code for IDS Cortisol?

The FDA product code for IDS Cortisol is CGR.

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 K161158IDS-iSYS Intact PTHN K190121IDS SHBG K200475IDS-iSYS Ostase BAP

Related Devices (Code: CGR)

K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd. K203270IMMULITE/IMMULITE® 1000 CortisolSiemens Healthcare Diagnostics Products, Ltd. K223038Access CortisolBeckman Coulter, Inc. K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman 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.