510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981059Substantially Equivalent

Acetaminophen-Sl Assay, Catalogue # 505-10, 505-30.

Sekisui Diagnostics P.E.I. Inc., Charlottestown,Pei,Canada, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981059 is the FDA 510(k) clearance record for ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30., a class II device, cleared for Diagnostic Chemicals , Ltd. 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 K981059.

Clearance record

Decision date
Received
(50 days to decision)
Product code
LDP Colorimetry, Acetaminophen
Regulation
21 CFR 862.3030
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Diagnostic Chemicals , Ltd. 16 First St., Charlottestown,Pei,Canada, CA
510(k) summary
Statement
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