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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
Applicant
SERIM RESEARCH CORP.
3506 reedy dr
elkhart,  IN  46514
Applicant Contact patricia rupchock
Correspondent
SERIM RESEARCH CORP.
3506 reedy dr
elkhart,  IN  46514
Correspodent 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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