510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831295Substantially Equivalent

Amylase Reagent #88129

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

K831295 is the FDA 510(k) clearance record for AMYLASE REAGENT #88129, a class II device, cleared for Hi Chem, Inc. on under FDA product code KHM (Nephelometric, Amylase). FDA records list 52 510(k) clearances for Hi Chem, Inc., from to . As of , FDA records show no recalls naming K831295.

Clearance record

Decision date
Received
(71 days to decision)
Product code
KHM Nephelometric, Amylase
Regulation
21 CFR 862.1070
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Hi Chem, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KHM

Trailing 12 months

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

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