510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K961586Substantially Equivalent

Uric Acid-Sl Assay Catalogue No. 237-60

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

K961586 is the FDA 510(k) clearance record for URIC ACID-SL ASSAY CATALOGUE NO. 237-60, a class I device, cleared for Diagnostic Chemicals , Ltd. on under FDA product code KNK (Acid, Uric, Uricase (Colorimetric)). FDA records list 72 510(k) clearances for Sekisui Diagnostics P.E.I. Inc., from to . As of , FDA records show no recalls naming K961586.

Clearance record

Decision date
Received
(90 days to decision)
Product code
KNK Acid, Uric, Uricase (Colorimetric)
Regulation
21 CFR 862.1775
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostic Chemicals , Ltd. West Royalty Industrial Park,, Charlottetown, P.E.I., CA
510(k) summary
Statement
Third party review
No

Clearances, product code KNK

Trailing 12 months

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

FDA records show no clearances under product code KNK in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KNK, 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