510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953860Substantially Equivalent

Hichem Ise Diluent Kit 70008

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

K953860 is the FDA 510(k) clearance record for HICHEM ISE DILUENT KIT 70008, a class II device, cleared for Hichem Diagnostics on under FDA product code CGZ (Electrode, Ion-Specific, Chloride). FDA records list 41 510(k) clearances for Hichem Diagnostics, from to . As of , FDA records show no recalls naming K953860.

Clearance record

Decision date
Received
(20 days to decision)
Product code
CGZ Electrode, Ion-Specific, Chloride
Regulation
21 CFR 862.1170
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Hichem Diagnostics 231 N. Puente St., Brea CA
510(k) summary
Summary
Third party review
No

Clearances, product code CGZ

Trailing 12 months

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

FDA records show no clearances under product code CGZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CGZ, 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