Immunex CRP
FDA 510(k) K812881 · Armkel, LLC
510(k) numberK812881
Submission
- Device name
- Immunex CRP
- Applicant
- Armkel, LLC
Mchenry, IL, US - Received
- October 14, 1981
- Decision date
- October 26, 1981
- 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 Immunex CRP cleared by the FDA?
Immunex CRP (K812881) received a 510(k) decision of Substantially Equivalent on October 26, 1981, 12 days after the submission was received.
What is the product code of K812881?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.