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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, gardnerella vaginalis
510(k) Number K923133
Device Name AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS
Original Applicant
MICROPROBE CORP.
1725 220th street, s.e., 104
bothell,  WA  98021
Original Contact russel k enns
Regulation Number866.2660
Classification Product Code
MJM  
Date Received06/29/1992
Decision Date 09/25/1992
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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