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

Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

21 CFR 862.1555 / Clinical Chemistry
FDA source (opens on fda.gov)

JNB is the FDA product code for Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine, a class II device type, regulated under 21 CFR 862.1555. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JNB
Device name
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Regulation
21 CFR 862.1555
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
15
Ingested recalls
2

Clearances, product code JNB

By decision year
15 clearances under product code JNB with a decision year between 1981 and 2002, 1996 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code JNB by decision year
YearClearances
19812
19891
19941
19951
19964
19971
19992
20001
20011
20021

Applicants with the most clearances

Product code JNB
Applicants holding the most 510(k) clearances under product code JNB
ApplicantClearances
Bio-Rad2
Quantase, Ltd.2
Alpkem Corp.1
Biochemicals, Inc.1
Icn Biomedicals, Inc.1
Isolab, Inc.1
Micromass, Inc.1
Neometrics, Inc.1
P-L Biochemicals, Inc.1
Revvity Health Sciences, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code