Atlas FDA

KLN

14 FDA 510(k) clearances · Product code

37 daysmedian time to decision
228 days90th percentile
14clearances measured

FDA profile

Official device name
Radioimmunoassay, Cocaine Metabolite
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3250
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
PSYCHEMEDICS RIA COCAINE ASSAY (K010868)Psychemedics Corp.2001-11-06
URINE COCAINE METABOLITE DIRECT RIA KIT (I-125) (K913867)Immunalysis Corporation1991-09-19
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE (K913722)Roche Diagnostic Systems, Inc.1991-09-10
ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE (K912756)Roche Diagnostic Systems, Inc.1991-07-26
TARGET COCAINE METABOLITE-R (K910122)V-Tech, Inc.1991-03-19
TARGET COCAINE METABOLITE-V (K910123)V-Tech, Inc.1991-03-19
MILENIA COCAINE METABOLITE (K910044)Diagnostic Products Corp.1991-02-13
ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) (K905730)Roche Diagnostic Systems, Inc.1991-01-15
ABUSCREEN ONLINE TM FOR COCAINE METABOLITE (K904995)Roche Diagnostic Systems, Inc.1990-11-28
MICROMEDIC CRACKPOT RIA KIT (K880674)Icn Micromedic Systems1988-10-06
RESUB. URINE COCAINE META. DIRECT RIA KIT [I-125] (K871549)Immunalysis Corporation1987-06-16
COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5 (K870740)Diagnostic Products Corp.1987-03-19
DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT (K862218)Diagnostic Products Corp.1986-06-27
ABUSCREEN RADIOIMMUNOASSAY-COCAINE META (K830480)Hoffmann-La Roche, Inc.1983-03-24

Track KLN automatically

Every clearance here is in the API, with alerts when new ones post.