510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821719Substantially Equivalent

Ammonia Reagent

Gilford Diagnostics, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821719 is the FDA 510(k) clearance record for AMMONIA REAGENT, a class I device, cleared for Gilford Diagnostics on under FDA product code JIF (Enzymatic Method, Ammonia). FDA records list 50 510(k) clearances for Gilford Diagnostics, from to . As of , FDA records show no recalls naming K821719.

Clearance record

Decision date
Received
(14 days to decision)
Product code
JIF Enzymatic Method, Ammonia
Regulation
21 CFR 862.1065
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Gilford Diagnostics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JIF

Trailing 12 months

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

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