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

Radioimmunoassay, Cocaine Metabolite

21 CFR 862.3250 / Clinical Toxicology
FDA source (opens on fda.gov)

KLN is the FDA product code for Radioimmunoassay, Cocaine Metabolite, a class II device type, regulated under 21 CFR 862.3250. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KLN
Device name
Radioimmunoassay, Cocaine Metabolite
Regulation
21 CFR 862.3250
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
14
Ingested recalls
0

Clearances, product code KLN

By decision year
14 clearances under product code KLN with a decision year between 1983 and 2001, 1991 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code KLN by decision year
YearClearances
19831
19861
19872
19881
19901
19917
20011

Applicants with the most clearances

Product code KLN
Applicants holding the most 510(k) clearances under product code KLN
ApplicantClearances
Roche Diagnostic Systems, Inc.4
Siemens Healthcare Diagnostics Inc.3
Immunalysis Corporation2
V-Tech, Inc.2
Hoffmann-La Roche, Inc.1
Icn Micromedic Systems1
Psychemedics Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KLN.