510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800616Substantially Equivalent

Bun Reagent Kit #88108

Hi Chem, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800616 is the FDA 510(k) clearance record for BUN REAGENT KIT #88108, a class II device, cleared for Hi Chem, Inc. on under FDA product code CDS (Electrode, Ion Specific, Urea Nitrogen). FDA records list 52 510(k) clearances for Hi Chem, Inc., from to . As of , FDA records show no recalls naming K800616.

Clearance record

Decision date
Received
(23 days to decision)
Product code
CDS Electrode, Ion Specific, Urea Nitrogen
Regulation
21 CFR 862.1770
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Hi Chem, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code CDS

Trailing 12 months

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

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