510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K843270Substantially Equivalent

Systemate Alkaline Phosphatase-67203

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

K843270 is the FDA 510(k) clearance record for SYSTEMATE ALKALINE PHOSPHATASE-67203, a class II device, cleared for Em Diagnostic Systems, Inc. on under FDA product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes). FDA records list 288 510(k) clearances for Em Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K843270.

Clearance record

Decision date
Received
(24 days to decision)
Product code
CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Regulation
21 CFR 862.1050
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Em Diagnostic Systems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CJE

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