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510(k) K003858

MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 by Phamatech — Product Code MVO

K003858 is an FDA 510(k) premarket notification submitted by Phamatech for the device "MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175". The FDA issued a decision of Substantially Equivalent on February 12, 2001. The device falls under product code MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The Counter), a Class U device. Phamatech has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2001
Date Received
December 13, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Device Class
Class U
Regulation Number
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 MVO

  • K040327 — ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, (April 19, 2004)
  • K030447 — AT HOME DRUG CUP, MODEL 9150X (April 14, 2003)
  • K014192 — LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, ST (May 23, 2002)
  • K013778 — PEACE OF MIND HOME DRUG TEST (February 7, 2002)
  • K013409 — AT HOME DRUG TEST, MODEL 9074 (December 6, 2001)
  • K013410 — AT HOME DRUG TEST, MODEL 9064 (December 6, 2001)
  • K013412 — AT HOME DRUG TEST, MODEL 9069 (December 6, 2001)
  • K010654 — AT HOME DRUG TEST, MODEL 9078 T (April 5, 2001)
  • K010655 — AT HOME DRUG TESTT, MODEL 9150 T (April 5, 2001)
  • K010653 — AT HOME DRUG TEST, MODEL 9068 T (April 5, 2001)

FDA data resources