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FDA 510(k) Application Details - K973210
Device Classification Name
Cells, Animal And Human, Cultured
More FDA Info for this Device
510(K) Number
K973210
Device Name
Cells, Animal And Human, Cultured
Applicant
DIAGNOSTIC HYBRIDS, INC.
ONE PRESIDENT ST.
ATHENS, OH 45701 US
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Contact
J. L. BROWN
Other 510(k) Applications for this Contact
Regulation Number
864.2280
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Classification Product Code
KIR
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More FDA Info for this Product Code
Date Received
08/27/1997
Decision Date
09/25/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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