FDA 510(k)

IMMULITE® 2000 Cortisol

K-Number: K202826 · 2021-01-15

ApplicantSiemens Healthcare Diagnostics Products, Ltd.

Decision Date2021-01-15

Product CodeCGR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IMMULITE® 2000 Cortisol is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K202826. 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 IMMULITE® 2000 Cortisol?

IMMULITE® 2000 Cortisol is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Siemens Healthcare Diagnostics Products, Ltd.. The 510(k) number is K202826.

When did IMMULITE® 2000 Cortisol receive FDA 510(k) clearance?

IMMULITE® 2000 Cortisol received FDA 510(k) clearance on 2021-01-15, under 510(k) number K202826.

Who is the listed applicant for IMMULITE® 2000 Cortisol?

The FDA 510(k) record lists Siemens Healthcare Diagnostics Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE® 2000 Cortisol?

The FDA product code for IMMULITE® 2000 Cortisol is CGR.

Other records listing Siemens Healthcare Diagnostics Products, Ltd. as applicant

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Related Devices (Code: CGR)

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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.