510(k) K850054

RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI by E.I. Dupont DE Nemours & Co., Inc. — Product Code CIB

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