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FDA 510(k) Application Details - K071971
Device Classification Name
Urinary Homocystine (Nonquantitative) Test System
More FDA Info for this Device
510(K) Number
K071971
Device Name
Urinary Homocystine (Nonquantitative) Test System
Applicant
DIAZYME LABORATORIES
12889 GREGG COURT
POWAY, CA 92064 US
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Contact
CHARLES YU
Other 510(k) Applications for this Contact
Regulation Number
862.1377
More FDA Info for this Regulation Number
Classification Product Code
LPS
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More FDA Info for this Product Code
Date Received
07/17/2007
Decision Date
09/17/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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