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FDA 510(k) Application Details - K992976
Device Classification Name
Myoglobin, Antigen, Antiserum, Control
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510(K) Number
K992976
Device Name
Myoglobin, Antigen, Antiserum, Control
Applicant
KAMIYA BIOMEDICAL CO.
910 INDUSTRY DR.
SEATTLE, WA 98188-3412 US
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Contact
COLIN GETTY
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Regulation Number
866.5680
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Classification Product Code
DDR
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Date Received
09/03/1999
Decision Date
11/01/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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