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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
Applicant
ABBOTT LABORATORIES
dept: 09v8 bldg: ap5-2
100 abbott park road
abbott park,  IL  60064 -3500
Applicant Contact matt klamrzynski
Correspondent
ABBOTT LABORATORIES
dept: 09v8 bldg: ap5-2
100 abbott park road
abbott park,  IL  60064 -3500
Correspondent Contact matt klamrzynski
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received09/27/1993
Decision Date 12/08/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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