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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, Trichomonas Vaginalis
510(k) Number K922457
FOIA Releasable 510(k) K922457
Device Name AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA
Applicant
Microprobe Corp.
1725 220th St., SE, 104
Bothell,  WA  98021
Applicant Contact RUSSEL K ENNS
Correspondent
Microprobe Corp.
1725 220th St., SE, 104
Bothell,  WA  98021
Correspondent Contact RUSSEL K ENNS
Regulation Number866.2660
Classification Product Code
MJK  
Date Received05/26/1992
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
Predetermined Change
Control Plan Authorized		 No
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