510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K904306Substantially Equivalent

Dupont Drug Calibrator-a

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

K904306 is the FDA 510(k) clearance record for DUPONT DRUG CALIBRATOR-A, a class I device, cleared for E.I. Dupont DE Nemours & Co., Inc. on under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)). FDA records list 253 510(k) clearances for E.I. Dupont DE Nemours & Co., Inc., from to . As of , FDA records show no recalls naming K904306.

Clearance record

Decision date
Received
(26 days to decision)
Product code
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
E.I. Dupont DE Nemours & Co., Inc. Medical Products Dept., Wilmington DE
Third party review
No

Clearances, product code JJX

Trailing 12 months

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

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