RCRP Flex reagent cartridge— 510(k) K221119
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K221119 for RCRP Flex reagent cartridge, Substantially Equivalent on 2023-03-17. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Product code
- Code DCN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tarrytown, NY, US
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More clearances from Siemens Healthcare Diagnostics, Inc.
view allRecalls naming K221119
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K221119.
Data sourced from openFDA. This site is unofficial and independent of the FDA.