510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051114Substantially Equivalent

Sentinel Ammonia Ultra Diagnostic Assay

Sentinel CH SpA, Milano, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051114 is the FDA 510(k) clearance record for SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY, a class I device, cleared for Sentinel Ch. Srl on under FDA product code JIF (Enzymatic Method, Ammonia). FDA records list 22 510(k) clearances for Sentinel Ch. Srl, from to . As of , FDA records show one recall naming K051114.

Clearance record

Decision date
Received
(207 days to decision)
Product code
JIF Enzymatic Method, Ammonia
Regulation
21 CFR 862.1065
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Sentinel Ch. Srl 5 Via Principe Eugenio, Milano, IT
510(k) summary
Summary PDF
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