510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000055Substantially Equivalent

Creatinine-S Assay, Model 221-30, 221-50, 221-17

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

K000055 is the FDA 510(k) clearance record for CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17, a class II device, cleared for Diagnostic Chemicals , Ltd. on under FDA product code CGX (Alkaline Picrate, Colorimetry, Creatinine). FDA records list 72 510(k) clearances for Sekisui Diagnostics P.E.I. Inc., from to . As of , FDA records show no recalls naming K000055.

Clearance record

Decision date
Received
(42 days to decision)
Product code
CGX Alkaline Picrate, Colorimetry, 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
Statement
Third party review
No

Clearances, product code CGX

Trailing 12 months
2 clearances under product code CGX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260