Atlas FDA

DLN

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3250
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE (K950134)E.I. Dupont DE Nemours & Co., Inc.1995-03-21
ABUSCREEN ONLINE FOR COCAINE METABOLITE (K924113)Roche Diagnostic Systems, Inc.1992-12-28
HIM TEST COCAINE (K792429)Tecknam, Inc.1979-12-07
COCAINE KIT, TOXI-PAK (K760401)J.T. Baker Chemical Co.1976-08-26

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