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510(k) K860303

DUPONT PHENOBARBITAL CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc. — Product Code LFN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1986
Date Received
January 28, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nephelometric Inhibition Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
Review Panel
TX
Submission Type

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

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  • K953724 — CRONEX RADIATION THERAPY CASSETTE (September 6, 1995)
  • 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)
  • 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 LFN

  • K934388 — QMS PHENOBARBITAL (February 25, 1994)
  • K864612 — DART PHENOBARBITAL ASSAY SYSTEM (January 13, 1987)
  • K860304 — DUPONT PHENOBARBITAL ASSAY (February 28, 1986)
  • K821543 — IPA FOR DETECTION OF PHENOBARBITAL (June 3, 1982)