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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
Applicant
MICROPROBE CORP.
1725 220TH STREET, S.E., 104
BOTHELL,  WA  98021
Applicant Contact RUSSEL K ENNS
Correspondent
MICROPROBE CORP.
1725 220TH STREET, S.E., 104
BOTHELL,  WA  98021
Correspondent Contact RUSSEL K ENNS
Regulation Number866.2660
Classification Product Code
MJM  
Date Received06/29/1992
Decision Date 09/25/1992
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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