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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 K851225
Device Name URINE DUO
Applicant
Culture Kits, Inc.
14 Prentice St.
P.O. Box 748
Norwich,  NY  13815
Applicant Contact STEPHANIE G PITZER
Correspondent
Culture Kits, Inc.
14 Prentice St.
P.O. Box 748
Norwich,  NY  13815
Correspondent Contact STEPHANIE G PITZER
Regulation Number866.1700
Classification Product Code
JTZ  
Date Received03/26/1985
Decision Date 08/13/1985
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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