510(k) Premarket Notification

• Device Classification Name: respiratory virus panel nucleic acid assay system
• 510(K) Number: K111387
• Model: 40-03778, 40-03010
• Device Name: LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
• Applicant: IQUUM INC; 700 nickerson road; marlborough, MA 01762 4663
• Contact: lingjun chen
• Regulation Number: 866.3980
• Classification Product Code: OCC
• Subsequent Product Code: OOI
• Date Received: 05/18/2011
• Decision Date: 08/04/2011
• Decision: substantially equivalent - CLIA submission (CS)
• 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