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510(k) K013124

MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP by Branan Medical Corp. — Product Code DJJ

K013124 is an FDA 510(k) premarket notification submitted by Branan Medical Corp. for the device "MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP". The FDA issued a decision of Substantially Equivalent on November 7, 2001. The device falls under product code DJJ (Fluorometry, Morphine), a Class II device regulated under 21 CFR 862.3640. Branan Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 2001
Date Received
September 19, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometry, Morphine
Device Class
Class II
Regulation Number
862.3640
Review Panel
TX
Submission Type

Other clearances by Branan Medical Corp.

  • K122633 — TOXCUP DRUG SCREEN CUP (February 7, 2013)
  • 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)
  • 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)

FDA data resources