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

L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase

21 CFR 862.1460 / Clinical Chemistry
FDA source (opens on fda.gov)

JGG is the FDA product code for L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase, a class I device type, regulated under 21 CFR 862.1460. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JGG
Device name
L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase
Regulation
21 CFR 862.1460
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code JGG

By decision year
2 clearances under product code JGG with a decision year between 1985 and 1989, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JGG by decision year
YearClearances
19851
19891

Applicants with the most clearances

Product code JGG
Applicants holding the most 510(k) clearances under product code JGG
ApplicantClearances
Alladin Diagnostic, Inc.1
Beckman Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code