Atlas FDA

LAT

16 FDA 510(k) clearances · Product code

61 daysmedian time to decision
360 days90th percentile
16clearances measured

FDA profile

Official device name
Radioimmunoassay, Cannabinoid(S)
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3870
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
PSYCHEMEDICS RIA CANNABINOID ASSAY (K011426)Psychemedics Corp.2002-05-03
ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 (K961620)Roche Diagnostic Systems, Inc.1996-06-13
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION (K936135)Sudormed, Inc.1996-06-10
DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE (K914507)Diagnostic Products Corp.1991-12-18
ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT (K913414)Roche Diagnostic Systems, Inc.1991-09-25
URINE THC DIRECT RIA KIT (I-125) (K913865)Immunalysis Corporation1991-09-18
ABUSCREEN ONLINE FOR THC (50 AND 100) (K912574)Roche Diagnostic Systems, Inc.1991-08-12
ABUSCREEN ONLINE TM FOR THC (K904996)Roche Diagnostic Systems, Inc.1991-01-11
ORAL THC-CANNABINOIDS DIRECT RIA KIT (K843534)Immunalysis Corporation1984-10-30
URINE THC CANNABINOIDS DIRECT RIA KIT (K833911)Immunalysis Corporation1984-01-24
ORAL THC-CANNABINOIDS DIRECT RIA KIT (K821965)Immunalysis Corporation1982-07-20
THC-CANNABINOIDS DIRECT URINE RIA KIT (K820903)Immunalysis Corporation1982-05-05
ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI (K820391)Hoffmann-La Roche, Inc.1982-03-08
EMIT -D.A.U. CANNABINOID URINE ASSAY (K800246)Syva Co.1980-02-26
TETRAHYDROCANNALBINOL DIRECT BLOOD KIT (K791649)Immunalysis Corporation1979-10-11
THC DIRECT RIA KIT (K781048)Immunalysis Corporation1978-10-03

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