510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K851125Substantially Equivalent

Aca Prothrombin Time Analytical Test Pack

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

K851125 is the FDA 510(k) clearance record for ACA PROTHROMBIN TIME ANALYTICAL TEST PACK, a class II device, cleared for E.I. Dupont DE Nemours & Co., Inc. on under FDA product code GJS (Test, Time, Prothrombin). 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 K851125.

Clearance record

Decision date
Received
(71 days to decision)
Product code
GJS Test, Time, Prothrombin
Regulation
21 CFR 864.7750
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 GJS

Trailing 12 months

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

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