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
K925612Substantially Equivalent

Hi Chem Electrolyte Buffer

Hichem Diagnostics, Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925612 is the FDA 510(k) clearance record for HI CHEM ELECTROLYTE BUFFER, a class II device, cleared for Hichem Diagnostics on under FDA product code JGS (Electrode, Ion Specific, Sodium). FDA records list 41 510(k) clearances for Hichem Diagnostics, from to . As of , FDA records show no recalls naming K925612.

Clearance record

Decision date
Received
(166 days to decision)
Product code
JGS Electrode, Ion Specific, Sodium
Regulation
21 CFR 862.1665
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Hichem Diagnostics 231 N. Puente St., Brea CA
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