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510(k) K040203

MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 by Branan Medical Corp. — Product Code DKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2004
Date Received
January 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

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  • 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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