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FDA 510(k) Application Details - K963909
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K963909
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
DIRECT SOLUTIONS
7 HAYRICK LN.
P.O. BOX 900
WESTFORD, MA 01886 US
Other 510(k) Applications for this Company
Contact
BILL DONOHUE
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
09/30/1996
Decision Date
11/08/1996
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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