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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae
510(k) Number K880076
Device Name G-MARK
Applicant
Bainbridge Laboratories, Inc.
7861 Day Rd. W.
Bainbridge Island,  WA  98110
Applicant Contact STEFAN L PACKELL
Correspondent
Bainbridge Laboratories, Inc.
7861 Day Rd. W.
Bainbridge Island,  WA  98110
Correspondent Contact STEFAN L PACKELL
Regulation Number866.3390
Classification Product Code
LIC  
Date Received01/11/1988
Decision Date 07/01/1988
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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