Home / 510(k) Clearances / K950135

510(k) K950135

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1995
Date Received
January 13, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by E.I. Dupont DE Nemours & Co., Inc.

  • K951851 — ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY (July 24, 1996)
  • K953725 — CRONEX RADIATION THERAPY VERIFICATION CASSETTE (September 6, 1995)
  • K953724 — CRONEX RADIATION THERAPY 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)
  • K950427 — URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE (March 21, 1995)
  • K950182 — URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (March 21, 1995)
  • K950134 — URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE (March 21, 1995)

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