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FDA 510(k) Application Details - K072631
Device Classification Name
More FDA Info for this Device
510(K) Number
K072631
Device Name
JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
Applicant
IDAHO TECHNOLOGY, INC.
390 Wakara Way
Salt Lake City, UT 84108 US
Other 510(k) Applications for this Company
Contact
BETH LINGENFELTER
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
NHT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/18/2007
Decision Date
12/20/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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