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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 K962217
Device Name GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT
Original Applicant
GEN-PROBE, INC.
9880 campus point dr.
san diego,  CA  92121
Original Contact gerald h schell
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received06/10/1996
Decision Date 11/27/1996
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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