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510(k) K950134

URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE by E.I. Dupont DE Nemours & Co., Inc. — Product Code DLN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1995
Date Received
January 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)
Device Class
Class II
Regulation Number
862.3250
Review Panel
TX
Submission Type

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  • K950427 — URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (March 21, 1995)
  • K950182 — URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (March 21, 1995)

Other clearances for product code DLN

  • K924113 — ABUSCREEN ONLINE FOR COCAINE METABOLITE (December 28, 1992)
  • K792429 — HIM TEST COCAINE (December 7, 1979)
  • K760401 — COCAINE KIT, TOXI-PAK (August 26, 1976)