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510(k) K950182

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

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

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  • K953725 — CRONEX RADIATION THERAPY VERIFICATION CASSETTE (September 6, 1995)
  • K951441 — DUPONT ACA DIGOXIN (DGN A) METHOD (June 1, 1995)
  • K950137 — URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE (April 13, 1995)
  • K950136 — URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • K950181 — URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • K950135 — URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE (March 30, 1995)
  • K950134 — URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE (March 21, 1995)
  • K950427 — URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (March 21, 1995)

Other clearances for product code DIW

  • K930845 — ROCHE ABUSCREEN ONTRAK FOR METHADONE (April 20, 1993)
  • K801509 — HI-M-TEST FOR METHADONE TEST #2 (July 14, 1980)
  • K760075 — KIT, METHADONE (TOXI-PAK IMMUNO HI) (July 20, 1976)