Revised C-Reactive Protein (RCRP) Flex Reagent Cartridge
FDA 510(k) K990825 · Dade Behring, Inc.
510(k) numberK990825
Submission
- Device name
- Revised C-Reactive Protein (RCRP) Flex Reagent Cartridge
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- March 12, 1999
- Decision date
- April 16, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Revised C-Reactive Protein (RCRP) Flex Reagent Cartridge cleared by the FDA?
Revised C-Reactive Protein (RCRP) Flex Reagent Cartridge (K990825) received a 510(k) decision of Substantially Equivalent on April 16, 1999, 35 days after the submission was received.
What is the product code of K990825?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.