510(k) Premarket Notification

• Device Classification Name: enzyme immunoassay, cannabinoids
• 510(K) Number: K122633
• Model: DT14, DT14S
• Device Name: TOXCUP DRUG SCREEN CUP
• Applicant: BRANAN MEDICAL CORP.; 140 technology dr ste 400; irvine, CA 92618
• Contact: olivia chan
• Regulation Number: 862.3870
• Classification Product Code: LDJ
• Subsequent Product Codes: DIO DIS DJC DJG DJR DKZ JXM JXN LCM LFG
• Date Received: 08/29/2012
• Decision Date: 02/07/2013
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Toxicology
• Review Advisory Committee: Clinical Chemistry
• summary: summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No