510(k) K950182

URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE by E.I. Dupont DE Nemours & Co., Inc. — Product Code DIW

K950182 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on March 21, 1995. The device falls under product code DIW (Hemagglutination Inhibition, Methadone), a Class II device regulated under 21 CFR 862.3620. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1995
Date Received
January 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemagglutination Inhibition, Methadone
Device Class
Class II
Regulation Number
862.3620
Review Panel
TX
Submission Type