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510(k) K950137

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

Clearance Details

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

Device Classification

Device Name
Enzyme Immunoassay, Barbiturate
Device Class
Class II
Regulation Number
862.3150
Review Panel
TX
Submission Type

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

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  • 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)
  • K950181 — URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE (April 5, 1995)
  • K950136 — URINE OPIATES 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)
  • K950182 — URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (March 21, 1995)

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