510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850054Substantially Equivalent

Rianen Angiotensin I Radioimmunoassay Ki

E.I. Dupont de Nemours & Co., Inc., N. Billerica MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850054 is the FDA 510(k) clearance record for RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI, a class II device, cleared for E.I. Dupont DE Nemours & Co., Inc. on under FDA product code CIB (Radioimmunoassay, Angiotensin I And Renin). FDA records list 253 510(k) clearances for E.I. Dupont DE Nemours & Co., Inc., from to . As of , FDA records show 2 recalls naming K850054.

Clearance record

Decision date
Received
(80 days to decision)
Product code
CIB Radioimmunoassay, Angiotensin I And Renin
Regulation
21 CFR 862.1085
Device class
Class II
Review panel
Clinical Chemistry
Applicant
E.I. Dupont DE Nemours & Co., Inc. 331 Treble Cove Rd., N. Billerica MA
Third party review
No

Clearances, product code CIB

Trailing 12 months

FDA records hold no clearances under product code CIB in the trailing twelve months.

FDA records show no clearances under product code CIB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CIB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260