510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843202Substantially Equivalent

Heparin Calibrator Aca

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

K843202 is the FDA 510(k) clearance record for HEPARIN CALIBRATOR ACA, a class II device, cleared for E.I. Dupont DE Nemours & Co., Inc. on under FDA product code KFF (Assay, Heparin). 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 K843202.

Clearance record

Decision date
Received
(108 days to decision)
Product code
KFF Assay, Heparin
Regulation
21 CFR 864.7525
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 KFF

Trailing 12 months
1 clearance under product code KFF in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KFF, 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 20261
October 20260