510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812628Substantially Equivalent

Aca Fibrinogen Calibrator

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

K812628 is the FDA 510(k) clearance record for ACA FIBRINOGEN CALIBRATOR, a class II device, cleared for E.I. Dupont DE Nemours & Co., Inc. on under FDA product code GFX (Fibrinogen Standard). 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 K812628.

Clearance record

Decision date
Received
(70 days to decision)
Product code
GFX Fibrinogen Standard
Regulation
21 CFR 864.7340
Device class
Class II
Review panel
Hematology
Applicant
E.I. Dupont DE Nemours & Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GFX

Trailing 12 months

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

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