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FDA 510(k) Application Details - K971406
Device Classification Name
Multi-Analyte Controls, All Kinds (Assayed)
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510(K) Number
K971406
Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Applicant
BOSTON BIOMEDICA, INC.
375 WEST ST.
WEST BRIDGEWATER, MA 02379 US
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Contact
PATRICIA E GARRETT
Other 510(k) Applications for this Contact
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
04/16/1997
Decision Date
08/07/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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