510(k) K850054
K850054 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI". The FDA issued a decision of Substantially Equivalent on March 29, 1985. The device falls under product code CIB (Radioimmunoassay, Angiotensin I And Renin), a Class II device regulated under 21 CFR 862.1085. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 1985
- Date Received
- January 8, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Angiotensin I And Renin
- Device Class
- Class II
- Regulation Number
- 862.1085
- Review Panel
- CH
- Submission Type