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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 a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-03-17 under approval 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. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K221119.

When was RCRP Flex reagent cartridge approved by the FDA?

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

What company makes RCRP Flex reagent cartridge?

RCRP Flex reagent cartridge is manufactured by Siemens Healthcare Diagnostics, Inc..

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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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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