Documento fuente o registro público
FDA 510(k) K221119 — RCRP Flex reagent cartridge
FDA 510(k) index record K221119. Device: RCRP Flex reagent cartridge. Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2023-03-17.
Fuente
"device_name": "RCRP Flex reagent cartridge"
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Automated FDA record verification
2026-10-20
2026-10-29
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FDA 510(k) public index record K221119.
Device name: RCRP Flex reagent cartridge. Applicant as listed: Siemens Healthcare Diagnostics, Inc..
Decision date: 2023-03-17. Decision wording: Substantially Equivalent.
Product code: DCN. Regulation: 21 CFR 866.5270. Medical specialty: Immunology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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