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

Thin Layer Chromatography, Tricyclic Antidepressant Drugs

21 CFR 862.3910 / Clinical Toxicology
FDA source (opens on fda.gov)

MLK is the FDA product code for Thin Layer Chromatography, Tricyclic Antidepressant Drugs, a class II device type, regulated under 21 CFR 862.3910. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MLK
Device name
Thin Layer Chromatography, Tricyclic Antidepressant Drugs
Regulation
21 CFR 862.3910
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code MLK

By decision year
2 clearances under product code MLK with a decision year between 2001 and 2002, 2001 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MLK by decision year
YearClearances
20011
20021

Applicants with the most clearances

Product code MLK
Applicants holding the most 510(k) clearances under product code MLK
ApplicantClearances
Alfa Scientific Designs, Inc.1
Branan Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code