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FDA 510(k) Application Details - K972868
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
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510(K) Number
K972868
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
BIONOSTICS, INC.
2 CRAIG RD.
ACTON, MA 01720 US
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Contact
BRUCE R WILLIAMS
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Regulation Number
862.1660
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Classification Product Code
JJY
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More FDA Info for this Product Code
Date Received
08/04/1997
Decision Date
08/28/1997
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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