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FDA 510(k)

IMMULITE/IMMULITE® 1000 Cortisol

K-Number: K203270 · 2021-01-15

ApplicantSiemens Healthcare Diagnostics Products, Ltd.
Decision Date2021-01-15
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE/IMMULITE® 1000 Cortisol is a medical device manufactured by Siemens Healthcare Diagnostics Products, Ltd.. It received FDA 510(k) clearance on 2021-01-15 under approval number K203270. 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/IMMULITE® 1000 Cortisol?

IMMULITE/IMMULITE® 1000 Cortisol is a medical device that received FDA 510(k) clearance on 2021-01-15. It is manufactured by Siemens Healthcare Diagnostics Products, Ltd.. The 510(k) number is K203270.

When was IMMULITE/IMMULITE® 1000 Cortisol approved by the FDA?

IMMULITE/IMMULITE® 1000 Cortisol received FDA 510(k) clearance on 2021-01-15, under approval number K203270.

What company makes IMMULITE/IMMULITE® 1000 Cortisol?

IMMULITE/IMMULITE® 1000 Cortisol is manufactured by Siemens Healthcare Diagnostics Products, Ltd..

What is the FDA product code for IMMULITE/IMMULITE® 1000 Cortisol?

The FDA product code for IMMULITE/IMMULITE® 1000 Cortisol is CGR.

Other Devices by Siemens Healthcare Diagnostics Products, Ltd.

K202826IMMULITE® 2000 Cortisol K213510IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA K233946IMMULITE® 2000 BR-MA PMA P010053Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) PMA P010051Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) PMA P010050Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

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Related Devices (Code: CGR)

K202136IDS CortisolImmunodiagnostic Systems , Ltd. K202826IMMULITE® 2000 CortisolSiemens Healthcare Diagnostics Products, Ltd. K223038Access CortisolBeckman Coulter, Inc. K242190Access Cortisol; DxC 500i Clinical AnalyzerBeckman Coulter, Inc.

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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