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FDA 510(k) Application Details - K973099
Device Classification Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K973099
Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Applicant
DADE CHEMISTRY SYSTEMS, INC.
GLASGOW SITE
P.O. BOX 6101
NEWARK, DE 19714-6101 US
Other 510(k) Applications for this Company
Contact
REBECCA S AYASH
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
08/19/1997
Decision Date
09/29/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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