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510(k) K841532

ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES by E.I. Dupont DE Nemours & Co., Inc. — Product Code LFG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1984
Date Received
April 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class
Class II
Regulation Number
862.3910
Review Panel
TX
Submission Type

Intended to measure any of the tricyclic antidepressant drugs in serum or urine.

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

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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)
  • 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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  • K980249 — ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (March 13, 1998)
  • K870823 — EMIT NORTRIPTYLINE ASSAY (March 20, 1987)
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