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FDA 510(k) Application Details - K062808
Device Classification Name
Urinary Homocystine (Nonquantitative) Test System
More FDA Info for this Device
510(K) Number
K062808
Device Name
Urinary Homocystine (Nonquantitative) Test System
Applicant
CATCH INCORPORATED
21031 SE 202ND STREET
RENTON, WA 98058 US
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Contact
Cindy Green
Other 510(k) Applications for this Contact
Regulation Number
862.1377
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Classification Product Code
LPS
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More FDA Info for this Product Code
Date Received
09/19/2006
Decision Date
10/13/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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