Rapitex (R) CRP New
FDA 510(k) K903853 · Behring Diagnostics, Inc.
510(k) numberK903853
Submission
- Device name
- Rapitex (R) CRP New
- Applicant
- Behring Diagnostics, Inc.
Somerville, NJ, US - Received
- August 21, 1990
- Decision date
- August 30, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Rapitex (R) CRP New cleared by the FDA?
Rapitex (R) CRP New (K903853) received a 510(k) decision of Substantially Equivalent on August 30, 1990, 9 days after the submission was received.
What is the product code of K903853?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.