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FDA 510(k) Application Details - K965213
Device Classification Name
Myoglobin, Antigen, Antiserum, Control
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510(K) Number
K965213
Device Name
Myoglobin, Antigen, Antiserum, Control
Applicant
DADE INTL., INC.
2173 NW 99TH AVE.
MIAMI, FL 33172 US
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Contact
RADHA GOOLABSINGH
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Regulation Number
866.5680
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Classification Product Code
DDR
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Date Received
12/30/1996
Decision Date
02/10/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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