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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reader, Zone, Automated
510(k) Number K932122
Device Name BIOMIC VIDEO PLATE READER
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 Number866.2850
Classification Product Code
KZK  
Date Received05/03/1993
Decision Date 03/01/1994
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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