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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Urine
510(k) Number K911846
Device Name URI-THREE(TM), MODIFICATION
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 Number866.2660
Classification Product Code
JXA  
Date Received04/18/1991
Decision Date 10/04/1991
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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