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FDA 510(k) Application Details - K060140
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K060140
Device Name
Calibrator, Secondary
Applicant
DIAGNOSTIC CHEMICALS LTD.
16 MCCARVILLE ST.
CHARLOTTETOWN, PE C1E 2A6 CA
Other 510(k) Applications for this Company
Contact
PENNY WHITE
Other 510(k) Applications for this Contact
Regulation Number
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/19/2006
Decision Date
04/24/2006
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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