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510(k) K040327

ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) by Accu-Stat Diagnostics, Inc. — Product Code MVO

K040327 is an FDA 510(k) premarket notification submitted by Accu-Stat Diagnostics, Inc. for the device "ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)". The FDA issued a decision of Substantially Equivalent on April 19, 2004. The device falls under product code MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The Counter), a Class U device. Accu-Stat Diagnostics, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2004
Date Received
February 10, 2004
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 Accu-Stat Diagnostics, Inc.

  • K041221 — ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AM (July 13, 2004)
  • K040629 — ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, O (May 5, 2004)

Other clearances for product code MVO

  • 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)
  • K013410 — AT HOME DRUG TEST, MODEL 9064 (December 6, 2001)
  • K013412 — AT HOME DRUG TEST, MODEL 9069 (December 6, 2001)
  • K013409 — AT HOME DRUG TEST, MODEL 9074 (December 6, 2001)
  • K010655 — AT HOME DRUG TESTT, MODEL 9150 T (April 5, 2001)
  • K010654 — AT HOME DRUG TEST, MODEL 9078 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)

FDA data resources