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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, yeast
510(k) Number K931151
Device Name AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA
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
MLA  
Date Received03/08/1993
Decision Date 06/18/1993
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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