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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
Model 1206620
Device Name UNI-GOLD CRYPTOSPORIDIUM
Original Applicant
TRINITY BIOTECH
5919 farnsworth ct.
carlsbad,  CA  92008
Original Contact lupe kagan
Regulation Number866.3220
Classification Product Code
MHJ  
Date Received05/29/2012
Decision Date 02/08/2013
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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