510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K903564Substantially Equivalent

Medisensor 2001

Medtest Systems, Inc., College Park MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903564 is the FDA 510(k) clearance record for MEDISENSOR 2001, a class II device, cleared for Medtest Systems, Inc. on under FDA product code JGS (Electrode, Ion Specific, Sodium). FDA records list one 510(k) clearance for Medtest Systems, Inc. As of , FDA records show no recalls naming K903564.

Clearance record

Decision date
Received
(419 days to decision)
Product code
JGS Electrode, Ion Specific, Sodium
Regulation
21 CFR 862.1665
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Medtest Systems, Inc. 335 Paint Branch Dr., College Park MD
Third party review
No

Clearances, product code JGS

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