510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K905658Substantially Equivalent

Systemate Creatinine (Epos Application) #65413

Em Diagnostic Systems, Inc., Gibbstown NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905658 is the FDA 510(k) clearance record for SYSTEMATE CREATININE (EPOS APPLICATION) #65413, a class II device, cleared for Em Diagnostic Systems, Inc. on under FDA product code CGX (Alkaline Picrate, Colorimetry, Creatinine). FDA records list 288 510(k) clearances for Em Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K905658.

Clearance record

Decision date
Received
(141 days to decision)
Product code
CGX Alkaline Picrate, Colorimetry, Creatinine
Regulation
21 CFR 862.1225
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Em Diagnostic Systems, Inc. 480 Democrat Rd., Gibbstown NJ
Third party review
No

Clearances, product code CGX

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