Synchron C-Reactive Protein Reagent
FDA 510(k) K910535 · Beckman Instruments, Inc.
510(k) numberK910535
Submission
- Device name
- Synchron C-Reactive Protein Reagent
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- February 8, 1991
- Decision date
- April 12, 1991
- 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 Synchron C-Reactive Protein Reagent cleared by the FDA?
Synchron C-Reactive Protein Reagent (K910535) received a 510(k) decision of Substantially Equivalent on April 12, 1991, 63 days after the submission was received.
What is the product code of K910535?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.