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510(k) K150162

First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test by W.H.P.M., Inc. — Product Code LAF

K150162 is an FDA 510(k) premarket notification submitted by W.H.P.M., Inc. for the device "First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test". The FDA issued a decision of Substantially Equivalent on February 26, 2015. The device falls under product code LAF (Gas Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. W.H.P.M., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2015
Date Received
January 26, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Chromatography, Methamphetamine
Device Class
Class II
Regulation Number
862.3610
Review Panel
TX
Submission Type

Other clearances by W.H.P.M., Inc.

  • K200754 — Hemosure Accu-Reader A100 (June 2, 2022)
  • K210327 — First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign (August 12, 2021)
  • K171695 — First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign (February 5, 2018)
  • K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign D (August 17, 2016)
  • K152551 — First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Bupr (November 9, 2015)
  • K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (June 29, 2015)
  • K142353 — First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test (October 7, 2014)
  • K052197 — FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST (June 9, 2006)
  • K051841 — WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST (August 22, 2005)
  • K041202 — HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST (August 12, 2004)

Other clearances for product code LAF

  • K203647 — SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (December 22, 2021)
  • K210212 — Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair (December 15, 2021)
  • K201442 — Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus (July 31, 2020)
  • K170222 — Rapid Tox Cup II (August 15, 2017)
  • K153693 — Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Cal (March 18, 2016)
  • K142293 — Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methampheta (September 18, 2015)
  • K150096 — Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclid (March 4, 2015)
  • K133047 — RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET (December 18, 2014)
  • K131652 — LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (March 21, 2014)
  • K111927 — PSYCHEMEDICS METHAMPHETAMINE EIA (May 1, 2012)

FDA data resources