510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180835Substantially Equivalent

SEKURE Acetaminophen L3K Assay

Sekisui Diagnostics P.E.I. Inc., Charlottetown,, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180835 is the FDA 510(k) clearance record for SEKURE Acetaminophen L3K Assay, a class II device, cleared for Sekisui Diagnostics P.E.I., Inc. on under FDA product code LDP (Colorimetry, Acetaminophen). FDA records list 72 510(k) clearances for Sekisui Diagnostics P.E.I., Inc., from to . As of , FDA records show no recalls naming K180835.

Clearance record

Decision date
Received
(315 days to decision)
Product code
LDP Colorimetry, Acetaminophen
Regulation
21 CFR 862.3030
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Sekisui Diagnostics P.E.I., Inc. 70 Watts Ave., Charlottetown,, CA
510(k) summary
Summary PDF
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