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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name indicator, physical/chemical sterilization process
510(k) Number K120652
Device Name RAPICIDE OPA-28 TEST STRIP
Original Applicant
SERIM RESEARCH CORP.
3506 reedy dr
elkhart,  IN  46514
Original Contact patricia rupchock
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received03/02/2012
Decision Date 10/12/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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