RCRP Flex reagent cartridge
FDA 510(k) K221119 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK221119
Submission
- Device name
- RCRP Flex reagent cartridge
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Tarrytown, NY, US - Received
- April 18, 2022
- Decision date
- March 17, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DCN – System, Test, C-Reactive Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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Questions and answers
When was RCRP Flex reagent cartridge cleared by the FDA?
RCRP Flex reagent cartridge (K221119) received a 510(k) decision of Substantially Equivalent on March 17, 2023, 333 days after the submission was received.
What is the product code of K221119?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.