510(k) Premarket Notification

• Device Classification Name: device, specimen collection
• 510(K) Number: K120846
• Device Name: TRANSPORT CULTURE MEDIUM DEVICE
• Applicant: PURITAN MEDICAL PRODUCTS LLC; 31 school street; p.o. box 149; guilford, ME 04443
• Contact: mehdi karamchi
• Regulation Number: 866.2900
• Classification Product Code: LIO
• Subsequent Product Codes: JTW JTX
• Date Received: 03/20/2012
• Decision Date: 06/08/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Microbiology
• Review Advisory Committee: Microbiology
• summary: summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No