510(k) Premarket Notification

• Device Classification Name: test, factor ii g20210a mutations, genomic dna pcr
• 510(K) Number: K100943
• Device Name: INVADER FACTOR II
• Applicant: HOLOGIC, INC.; 250 campus drive; marlborough, MA 01752
• Contact: randall covill
• Regulation Number: 864.7280
• Classification Product Code: NPR
• Date Received: 04/06/2010
• Decision Date: 06/02/2011
• Decision: substantially equivalent - CLIA submission (CS)
• Classification Advisory Committee: Hematology
• Review Advisory Committee: Hematology
• summary: summary
• FDA Review: Decision Summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No