510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843105Substantially Equivalent

Systemate Creatinine 67223

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

K843105 is the FDA 510(k) clearance record for SYSTEMATE CREATININE 67223, 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 K843105.

Clearance record

Decision date
Received
(20 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. 4221 Richmond Rd., NW, Walker MI
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