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510(k) K010654

AT HOME DRUG TEST, MODEL 9078 T by Phamatech — Product Code MVO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2001
Date Received
March 5, 2001
Clearance Type
Special
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

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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)
  • K013412 — AT HOME DRUG TEST, MODEL 9069 (December 6, 2001)
  • K013410 — AT HOME DRUG TEST, MODEL 9064 (December 6, 2001)
  • K013409 — AT HOME DRUG TEST, MODEL 9074 (December 6, 2001)
  • K010655 — AT HOME DRUG TESTT, MODEL 9150 T (April 5, 2001)
  • K010653 — AT HOME DRUG TEST, MODEL 9068 T (April 5, 2001)
  • K010646 — AT HOME DRUG TEST, MODEL 9083 T (March 30, 2001)