510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K974001Substantially Equivalent

Aspartate Aminotransferase-Sl Assay, Catalogue Number 319-10, 319-30

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

K974001 is the FDA 510(k) clearance record for ASPARTATE AMINOTRANSFERASE-SL ASSAY, CATALOGUE NUMBER 319-10, 319-30, a class II device, cleared for Diagnostic Chemicals , Ltd. on under FDA product code CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot). FDA records list 72 510(k) clearances for Sekisui Diagnostics P.E.I. Inc., from to . As of , FDA records show no recalls naming K974001.

Clearance record

Decision date
Received
(23 days to decision)
Product code
CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Regulation
21 CFR 862.1100
Device class
Class II
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 CIT

Trailing 12 months

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

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