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510(k) K961393

TRICYCLICS SERUM TOX ASSAY by Diagnostic Reagents, Inc. — Product Code LFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1996
Date Received
April 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
U.V. Spectrometry, Tricyclic Antidepressant Drugs
Device Class
Class II
Regulation Number
862.3910
Review Panel
TX
Submission Type

Other clearances by Diagnostic Reagents, Inc.

  • K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY (November 18, 1998)
  • K983812 — NAPA EIA ASSAY (November 16, 1998)
  • K983323 — DIGOXIN IMMUNOASSAY (November 12, 1998)
  • K983280 — VANCOMYCIN EIA ASSAY (November 6, 1998)
  • K983159 — DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS (November 5, 1998)
  • K973102 — LIDOCAINE EIA ASSAY (September 12, 1997)
  • K972835 — 50NG/ML COCAINE METABOLITE CALIBRATOR (August 28, 1997)
  • K972526 — METHADONE EIA ASSAY (August 4, 1997)
  • K964212 — QUINIDINE ENZYME IMMUNOASSAY (December 18, 1996)
  • K963835 — DIGOXIN ENZYME IMMUNOASSAY (December 10, 1996)

Other clearances for product code LFH

  • K231020 — Alinity c Tricyclic Antidepressants Reagent Kit (November 17, 2023)
  • K213875 — DRI TM Tricyclics Serum Tox Assay (December 21, 2022)
  • K983268 — MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY (November 18, 1998)
  • K981801 — ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (August 25, 1998)
  • K953761 — AXSYM TRICYCLIC ANTIDEPRESSANTS (November 22, 1995)