510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K842548Substantially Equivalent

Aca Acetaminophen Analytical Test Pack

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

K842548 is the FDA 510(k) clearance record for ACA ACETAMINOPHEN ANALYTICAL TEST PACK, a class II device, cleared for E.I. Dupont DE Nemours & Co., Inc. on under FDA product code LDP (Colorimetry, Acetaminophen). 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 K842548.

Clearance record

Decision date
Received
(45 days to decision)
Product code
LDP Colorimetry, Acetaminophen
Regulation
21 CFR 862.3030
Device class
Class II
Review panel
Clinical Toxicology
Applicant
E.I. Dupont DE Nemours & Co., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LDP

Trailing 12 months
1 clearance under product code LDP in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LDP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260