510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K955498Substantially Equivalent

Cholinesterase Assay Kit, Catalogue# 300-05

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

K955498 is the FDA 510(k) clearance record for CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05, a class I device, cleared for Diagnostic Chemicals , Ltd. on under FDA product code DIH (Colorimetry, Cholinesterase). FDA records list 72 510(k) clearances for Sekisui Diagnostics P.E.I. Inc., from to . As of , FDA records show no recalls naming K955498.

Clearance record

Decision date
Received
(54 days to decision)
Product code
DIH Colorimetry, Cholinesterase
Regulation
21 CFR 862.3240
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Diagnostic Chemicals , Ltd. West Royalty Industrial Park,, Charlottetown, P.E.I., CA
510(k) summary
Statement
Third party review
No

Clearances, product code DIH

Trailing 12 months

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

FDA records show no clearances under product code DIH in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DIH, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260