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FDA 510(k)

RCRP Flex reagent cartridge

K-Number: K221119 · 2023-03-17

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2023-03-17
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RCRP Flex reagent cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-03-17 under 510(k) number K221119. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RCRP Flex reagent cartridge?

RCRP Flex reagent cartridge is a medical device that received FDA 510(k) clearance on 2023-03-17. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K221119.

When did RCRP Flex reagent cartridge receive FDA 510(k) clearance?

RCRP Flex reagent cartridge received FDA 510(k) clearance on 2023-03-17, under 510(k) number K221119.

Who is the listed applicant for RCRP Flex reagent cartridge?

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

What is the FDA product code for RCRP Flex reagent cartridge?

The FDA product code for RCRP Flex reagent cartridge is DCN.

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Related Devices (Code: DCN)

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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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