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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Fluorescent (Direct Test), All Groups, N. Gonorrhoeae
510(k) Number K900546
Device Name BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT
Applicant
Baxter Healthcare Corp
P.O. Box 3093
Bellevue,  WA  98009
Applicant Contact AMY TAYLOR
Correspondent
Baxter Healthcare Corp
P.O. Box 3093
Bellevue,  WA  98009
Correspondent Contact AMY TAYLOR
Regulation Number866.3390
Classification Product Code
GTH  
Date Received02/05/1990
Decision Date 06/15/1990
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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