510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K172232Substantially Equivalent

LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600

Ams Diagnostics, Weston FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K172232 is the FDA 510(k) clearance record for LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600, a class II device, cleared for Ams Diagnostics on under FDA product code JGS (Electrode, Ion Specific, Sodium). FDA records list one 510(k) clearance for Ams Diagnostics. As of , FDA records show no recalls naming K172232.

Clearance record

Decision date
Received
(687 days to decision)
Product code
JGS Electrode, Ion Specific, Sodium
Regulation
21 CFR 862.1665
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ams Diagnostics 1790 N. Commerce Pkwy., Weston FL
510(k) summary
Statement
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