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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 K861835
Device Name MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST
Applicant
Syva Co.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Applicant Contact ELEANOR V CHIU
Correspondent
Syva Co.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Correspondent Contact ELEANOR V CHIU
Regulation Number866.3390
Classification Product Code
GTH  
Date Received05/13/1986
Decision Date 05/29/1986
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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