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510(k) K991465

DRUG STOP by Texas Immunology, Inc. — Product Code MVO

K991465 is an FDA 510(k) premarket notification submitted by Texas Immunology, Inc. for the device "DRUG STOP". The FDA issued a decision of Substantially Equivalent on December 10, 1999. The device falls under product code MVO (Kit, Test, Multiple, Drugs Of Abuse, Over The Counter), a Class U device. Texas Immunology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1999
Date Received
April 27, 1999
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 Texas Immunology, Inc.

  • K980153 — DRUG CHECK (March 27, 1998)
  • K973208 — FIRST SIGN (October 20, 1997)
  • K972094 — TARGET CARDIAC TROPONIN I TEST (July 23, 1997)
  • K963680 — TARGET MYOGLOBIN TEST (February 6, 1997)
  • K912246 — TARGET MICROALBUMINURIA TEST (July 19, 1991)
  • K910073 — TARGET ASO TEST (May 21, 1991)
  • K904105 — V-TREND TARGET RF TEST (October 15, 1990)
  • K892231 — V-TREND TARGET CRP TEST (April 21, 1989)
  • K890423 — V-TREND TARGET CRP TEST (February 17, 1989)
  • K890041 — V-TREND TARGET IM TEST (January 23, 1989)

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)
  • 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)

FDA data resources