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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, Selective And Differential
510(k) Number K853488
Device Name STAPH KIT
Applicant
Culture Kits, Inc.
14 Prentice St.
P.O. Box 748
Norwich,  NY  13815
Applicant Contact HOLLY L SWEET
Correspondent
Culture Kits, Inc.
14 Prentice St.
P.O. Box 748
Norwich,  NY  13815
Correspondent Contact HOLLY L SWEET
Regulation Number866.2360
Classification Product Code
JSI  
Date Received08/20/1985
Decision Date 08/28/1985
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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