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510(k) K010836

AT WORK DRUG TEST, MODEL 9147T AWT by Phamatech — Product Code LAF

K010836 is an FDA 510(k) premarket notification submitted by Phamatech for the device "AT WORK DRUG TEST, MODEL 9147T AWT". The FDA issued a decision of Substantially Equivalent on April 11, 2001. The device falls under product code LAF (Gas Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. Phamatech has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2001
Date Received
March 20, 2001
Clearance Type
Special
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 Phamatech

  • K181945 — QuickScreen Pro Multi Drug Screening Test, Model 9395Z (October 18, 2018)
  • K131069 — QUICKSCREEN AMPHETINE 500 TEST (May 14, 2014)
  • K103295 — QUICKSCREEN COCAINE 150 SCREENING TEST (February 1, 2012)
  • K070098 — QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREEN (December 7, 2007)
  • K070009 — AT HOME DRUG TEST MODELS, 9308T AND 9308X (December 7, 2007)
  • K043599 — MOMENTS MENOPAUSE CHECK, MODEL 9113 (February 25, 2005)
  • K043051 — QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 (February 7, 2005)
  • K043167 — PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND (December 29, 2004)
  • K041578 — QUICKSCREEN, MODELS 9177X AND 9178X (September 10, 2004)
  • K040575 — PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 (May 20, 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)
  • K150162 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (February 26, 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)

FDA data resources