510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K042270Substantially Equivalent

Stat K in Vitro Diagnostic Test System

Stat Chem, Inc., Orange CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042270 is the FDA 510(k) clearance record for STAT K IN VITRO DIAGNOSTIC TEST SYSTEM, a class II device, cleared for Stat Chem, Inc. on under FDA product code CEM (Electrode, Ion Specific, Potassium). FDA records list one 510(k) clearance for Stat Chem, Inc. As of , FDA records show no recalls naming K042270.

Clearance record

Decision date
Received
(44 days to decision)
Product code
CEM Electrode, Ion Specific, Potassium
Regulation
21 CFR 862.1600
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Stat Chem, Inc. 619 N. Poplar St., Orange CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CEM

Trailing 12 months
1 clearance under product code CEM 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 CEM, 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