FDA 510(k) Application Details - K132066

Device Classification Name	More FDA Info for this Device
510(K) Number	K132066
Device Name	INFLAMMA DRY
Applicant	RAPID PATHOGEN SCREENING, INC. 7227 DELAINEY COURT SARASOTA, FL 34240 US Other 510(k) Applications for this Company
Contact	Douglas Bueschel Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PFQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2013
Decision Date	11/21/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review