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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
510(k) Number K854521
Device Name BIOGRAM
Applicant
Giles Scientific, Inc.
250 Mercer St.
Suite A301
New York,  NY  10012
Applicant Contact DAVID L GIBBS
Correspondent
Giles Scientific, Inc.
250 Mercer St.
Suite A301
New York,  NY  10012
Correspondent Contact DAVID L GIBBS
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received11/12/1985
Decision Date 12/23/1985
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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