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FDA 510(k) Application Details - K041871
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K041871
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
TROUBLE SHOOTER CONSULING, INC.
VIA RINA MONTI N 26 C.A.P.
ROME 00155 IT
Other 510(k) Applications for this Company
Contact
Gary Lehnus
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
07/09/2004
Decision Date
08/16/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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