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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cryptosporidium Spp.
510(k) Number K121565
Device Name UNI-GOLD CRYPTOSPORIDIUM
Applicant
Trinity Biotech
5919 Farnsworth Ct.
Carlsbad,  CA  92008
Applicant Contact LUPE KAGAN
Correspondent
Trinity Biotech
5919 Farnsworth Ct.
Carlsbad,  CA  92008
Correspondent Contact LUPE KAGAN
Regulation Number866.3220
Classification Product Code
MHJ  
Date Received05/29/2012
Decision Date 02/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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