510(k) Premarket Notification

• Device Classification Name: enzyme immunoassay, phencyclidine
• 510(K) Number: K122703
• Device Name: RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
• Applicant: BIOPHOR DIAGNOSTICS, INC.; 1201 douglas ave; redwood city, CA 94063
• Contact: nathaniel g butlin
• Regulation Number: 862.3100
• Classification Product Code: LCM
• Subsequent Product Codes: DIF DKB
• Date Received: 09/04/2012
• Decision Date: 04/25/2013
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Toxicology
• Review Advisory Committee: Toxicology
• summary: summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No