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510(k) K013778

PEACE OF MIND HOME DRUG TEST by Advantage Diagnostics Corp. — Product Code MVO

K013778 is an FDA 510(k) premarket notification submitted by Advantage Diagnostics Corp. for the device "PEACE OF MIND HOME DRUG TEST". The FDA issued a decision of Substantially Equivalent on February 7, 2002. The device falls under product code MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The Counter), a Class U device. Advantage Diagnostics Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2002
Date Received
November 13, 2001
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 Advantage Diagnostics Corp.

  • K023712 — ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST (January 31, 2003)
  • K011962 — ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST (August 9, 2001)
  • K010921 — ADVANTAGE MARIJUANA (THC) HOME DRUG TEST (June 25, 2001)
  • K003708 — ADVANTAGE THC/COCAINE TEST (January 22, 2001)
  • K001567 — ADVANTAGE THC TEST (June 19, 2000)
  • K994227 — ADVANTAGE HCG TEST (URINE/SERUM) (February 3, 2000)
  • K991883 — REDI-TEST OPIATES (September 15, 1999)
  • K903416 — CANNULA, SURGICAL (November 23, 1990)
  • K881369 — ADVANCE DIAGNOSTICS DISPOSABLE EYECUP (May 13, 1988)

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)
  • 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