510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925553Substantially Equivalent

Hi Chem CO2 Alkaline Buffer Reagent Kit,prod#88813

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

K925553 is the FDA 510(k) clearance record for HI CHEM CO2 ALKALINE BUFFER REAGENT KIT,PROD#88813, a class II device, cleared for Hichem Diagnostics on under FDA product code JFL (Ph Rate Measurement, Carbon-Dioxide). FDA records list 41 510(k) clearances for Hichem Diagnostics, from to . As of , FDA records show no recalls naming K925553.

Clearance record

Decision date
Received
(101 days to decision)
Product code
JFL Ph Rate Measurement, Carbon-Dioxide
Regulation
21 CFR 862.1160
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 JFL

Trailing 12 months

FDA records hold no clearances under product code JFL in the trailing twelve months.

FDA records show no clearances under product code JFL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260