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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dna probe, nucleic acid amplification, chlamydia
510(k) Number K070174
Device Name AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY
Original Applicant
ROCHE DIAGNOSTICS CORPORATION
9115 hague road
indianapolis,  IN  46256
Original Contact theresa ambrose bush
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received01/18/2007
Decision Date 04/16/2007
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
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