Home / 510(k) Clearances / K983268

510(k) K983268

MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY by Diagnostic Reagents, Inc. — Product Code LFH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1998
Date Received
September 17, 1998
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.

  • 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)
  • K962463 — PROCAINAMIDE ENZYME IMMUNOASSAY (August 14, 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)
  • K981801 — ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (August 25, 1998)
  • K961393 — TRICYCLICS SERUM TOX ASSAY (June 12, 1996)
  • K953761 — AXSYM TRICYCLIC ANTIDEPRESSANTS (November 22, 1995)