Home / 510(k) Clearances / K112395

510(k) K112395

WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST by Guangzhou Wondfo Biotech Co., Ltd. — Product Code LFG

K112395 is an FDA 510(k) premarket notification submitted by Guangzhou Wondfo Biotech Co., Ltd. for the device "WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST". The FDA issued a decision of Substantially Equivalent on September 9, 2011. The device falls under product code LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Guangzhou Wondfo Biotech Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2011
Date Received
August 19, 2011
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 Guangzhou Wondfo Biotech Co., Ltd.

  • K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test (April 28, 2026)
  • K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test C (November 18, 2025)
  • K251289 — WELLlife COVID-19 Antigen Test Rx (October 22, 2025)
  • K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (September 30, 2024)
  • K241741 — SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Te (July 16, 2024)
  • K202567 — Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Pan (September 25, 2020)
  • K182701 — Wondfo T-Cup Multi-Drug Urine Test Cup (December 3, 2018)
  • K173229 — Preview Digital Pregnancy Test (March 12, 2018)
  • K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test (May 14, 2017)
  • K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test (June 27, 2016)

Other clearances for product code LFG

  • K151348 — Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptylin (August 18, 2015)
  • K142609 — CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (December 18, 2014)
  • 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)

FDA data resources