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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 K931374
Device Name AFFIRM VPIII MICROBIAL IDENTIFICATION TEST
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 Received03/18/1993
Decision Date 06/15/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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