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FDA 510(k) Application Details - K040434
Device Classification Name
Igg, Antigen, Antiserum, Control
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510(K) Number
K040434
Device Name
Igg, Antigen, Antiserum, Control
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250 US
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Contact
SHERRI L COENEN
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Regulation Number
866.5510
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Classification Product Code
DEW
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Date Received
02/19/2004
Decision Date
03/10/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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