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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Identification, Neisseria Gonorrhoeae
510(k) Number K870117
Device Name NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST
Applicant
Pro-Lab, Inc.
705 Progress Ave. Unit 3a
Scarborough Ont,  CA
Applicant Contact LYNN RAE
Correspondent
Pro-Lab, Inc.
705 Progress Ave. Unit 3a
Scarborough Ont,  CA
Correspondent Contact LYNN RAE
Regulation Number866.2660
Classification Product Code
JSX  
Date Received01/12/1987
Decision Date 03/20/1987
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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