510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K070383Substantially Equivalent

Enzymatic Creatinine Assay (265 Series)

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

K070383 is the FDA 510(k) clearance record for ENZYMATIC CREATININE ASSAY (265 SERIES), a class II device, cleared for Diagnostic Chemicals , Ltd. on under FDA product code JFY (Enzymatic Method, Creatinine). FDA records list 72 510(k) clearances for Sekisui Diagnostics P.E.I. Inc., from to . As of , FDA records show 2 recalls naming K070383.

Clearance record

Decision date
Received
(133 days to decision)
Product code
JFY Enzymatic Method, Creatinine
Regulation
21 CFR 862.1225
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diagnostic Chemicals , Ltd. 16 Mccarville St., Charlottetown, P.E., CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JFY

Trailing 12 months
1 clearance under product code JFY in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JFY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260