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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mmp-9 Test System
510(k) Number K132066
Device Name INFLAMMA DRY
Applicant
RAPID PATHOGEN SCREENING, INC.
7227 DELAINEY COURT
SARASOTA,  FL  34240
Applicant Contact Douglas Bueschel
Correspondent
RAPID PATHOGEN SCREENING, INC.
7227 DELAINEY COURT
SARASOTA,  FL  34240
Correspondent Contact Douglas Bueschel
Regulation Number862.1540
Classification Product Code
PFQ  
Subsequent Product Code
JJX  
Date Received07/03/2013
Decision Date 11/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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