510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844965Substantially Equivalent

Leucine Aminopeptidase Reagent

Alladin Diagnostic, Inc., Princeton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844965 is the FDA 510(k) clearance record for LEUCINE AMINOPEPTIDASE REAGENT, a class I device, cleared for Alladin Diagnostic, Inc. on under FDA product code JGG (L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase). FDA records list 2 510(k) clearances for Alladin Diagnostic, Inc., from to . As of , FDA records show no recalls naming K844965.

Clearance record

Decision date
Received
(71 days to decision)
Product code
JGG L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase
Regulation
21 CFR 862.1460
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Alladin Diagnostic, Inc. 84 Bayard Ln., Princeton NJ
Third party review
No

Clearances, product code JGG

Trailing 12 months

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

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