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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 K934622
Device Name LCX CHLAMYDIA TRACHOMATIS ASSAY
Original Applicant
ABBOTT LABORATORIES
dept: 09v8 bldg: ap5-2
100 abbott park road
abbott park,  IL  60064 3500
Original Contact matt klamrzynski
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received09/27/1993
Decision Date 12/08/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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