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510(k) K122633

TOXCUP DRUG SCREEN CUP by Branan Medical Corp. — Product Code LDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2013
Date Received
August 29, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Cannabinoids
Device Class
Class II
Regulation Number
862.3870
Review Panel
TX
Submission Type

Other clearances by Branan Medical Corp.

  • K122752 — FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX D (January 30, 2013)
  • K040203 — MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN (March 25, 2004)
  • K032057 — TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC (August 21, 2003)
  • K030113 — MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRU (July 2, 2003)
  • K023489 — QUICKTOX MULTIPLE DRUG DIPCARD (December 16, 2002)
  • K022355 — QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 (July 30, 2002)
  • K013124 — MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP (November 7, 2001)
  • K012541 — MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRU (September 4, 2001)
  • K010734 — BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 (July 30, 2001)
  • K004034 — MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 (March 8, 2001)

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