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FDA 510(k) Application Details - K060133
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K060133
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
INVERNESS MEDICAL INNOVATIONS, INC.
51 SAWYER RD., SUITE 200
WALTHAM, MA 02453-3448 US
Other 510(k) Applications for this Company
Contact
JAMES M DELANEY
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/18/2006
Decision Date
02/16/2006
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
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