510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801892Substantially Equivalent

Klinar Reagent Pak, #36010

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

K801892 is the FDA 510(k) clearance record for KLINAR REAGENT PAK, #36010, a class II device, cleared for Hi Chem, Inc. on under FDA product code JGT (Flame Photometry, Sodium). FDA records list 52 510(k) clearances for Hi Chem, Inc., from to . As of , FDA records show no recalls naming K801892.

Clearance record

Decision date
Received
(76 days to decision)
Product code
JGT Flame Photometry, Sodium
Regulation
21 CFR 862.1665
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 JGT

Trailing 12 months

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

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