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510(k) K142609

CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine by Guangzhou Wondfo Biotech Co., Ltd. — Product Code LFG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2014
Date Received
September 16, 2014
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.

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Other clearances for product code LFG

  • K151348 — Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptylin (August 18, 2015)
  • K112395 — WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST (September 9, 2011)
  • K072062 — UCP MULTIPLE DRUG SCREEN TEST CUPS (September 20, 2007)
  • K061457 — UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS (August 21, 2006)
  • K021526 — ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE (July 17, 2002)
  • K011545 — VERDICT -II TCA, VERDICT-II MTD (June 8, 2001)
  • K980249 — ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (March 13, 1998)
  • K870823 — EMIT NORTRIPTYLINE ASSAY (March 20, 1987)
  • K861155 — EMIT DESIPRAMINE ASSAY (May 2, 1986)
  • K853113 — TD TRICYCLIC ANTIDEPRESSANTS (August 12, 1985)