510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852519Substantially Equivalent

Dupont Aca Fibrin Degradation Prod Clotting Tube

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

K852519 is the FDA 510(k) clearance record for DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE, a class II device, cleared for E.I. Dupont DE Nemours & Co., Inc. on under FDA product code JCO (Bothrops Atrox Reagent). 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 K852519.

Clearance record

Decision date
Received
(56 days to decision)
Product code
JCO Bothrops Atrox Reagent
Regulation
21 CFR 864.8100
Device class
Class II
Review panel
Hematology
Applicant
E.I. Dupont DE Nemours & Co., Inc. Medical Products Dept., Wilmington DE
Third party review
No

Clearances, product code JCO

Trailing 12 months

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

FDA records show no clearances under product code JCO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JCO, 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