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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 the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostic Systems , Ltd.. It received FDA 510(k) clearance on 2021-04-13 under 510(k) 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. The listed applicant is Immunodiagnostic Systems , Ltd.. The 510(k) number is K202136.

When did IDS Cortisol receive FDA 510(k) clearance?

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

Who is the listed applicant for IDS Cortisol?

The FDA 510(k) record lists Immunodiagnostic Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDS Cortisol?

The FDA product code for IDS Cortisol is CGR.

Other records listing Immunodiagnostic Systems , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: CGR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

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.

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