510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K840961Substantially Equivalent

Eschweiler Combi-Analyser Mta-500

U.S. Science, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840961 is the FDA 510(k) clearance record for ESCHWEILER COMBI-ANALYSER MTA-500, a class II device, cleared for U.S. Science, Inc. on under FDA product code CEM (Electrode, Ion Specific, Potassium). FDA records list one 510(k) clearance for U.S. Science, Inc. As of , FDA records show no recalls naming K840961.

Clearance record

Decision date
Received
(157 days to decision)
Product code
CEM Electrode, Ion Specific, Potassium
Regulation
21 CFR 862.1600
Device class
Class II
Review panel
Clinical Chemistry
Applicant
U.S. Science, Inc. 4221 Richmond Rd., NW, Walker MI
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