Rapet CRP
FDA 510(k) K974429 · Stanbio Laboratory
510(k) numberK974429
Submission
- Device name
- Rapet CRP
- Applicant
- Stanbio Laboratory
San Antonio, TX, US - Received
- November 24, 1997
- Decision date
- February 18, 1998
- 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 Rapet CRP cleared by the FDA?
Rapet CRP (K974429) received a 510(k) decision of Substantially Equivalent on February 18, 1998, 86 days after the submission was received.
What is the product code of K974429?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.