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FDA 510(k) Application Details - K050029
Device Classification Name
Myeloperoxidase, Immunoassay, System, Test
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510(K) Number
K050029
Device Name
Myeloperoxidase, Immunoassay, System, Test
Applicant
PROGNOSTIX, INC.
10265 CARNEGIE AVENUE
CLEVELAND, OH 44106 US
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Contact
THOMAS M JACKSON
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Regulation Number
866.5600
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Classification Product Code
NTV
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More FDA Info for this Product Code
Date Received
01/06/2005
Decision Date
05/10/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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