Rianen Angiotensin I Radioimmunoassay Ki
FDA 510(k) K850054 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK850054
Submission
- Device name
- Rianen Angiotensin I Radioimmunoassay Ki
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
N. Billerica, MA, US - Received
- January 8, 1985
- Decision date
- March 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIB – Radioimmunoassay, Angiotensin I And Renin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1085
- Specialty
- Clinical Chemistry
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Questions and answers
When was Rianen Angiotensin I Radioimmunoassay Ki cleared by the FDA?
Rianen Angiotensin I Radioimmunoassay Ki (K850054) received a 510(k) decision of Substantially Equivalent on March 29, 1985, 80 days after the submission was received.
What is the product code of K850054?
The FDA product code is CIB – Radioimmunoassay, Angiotensin I And Renin, a Class II (moderate risk) device regulated under 21 CFR 862.1085.