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FDA 510(k) Application Details - K080851
Device Classification Name
Urinary Homocystine (Nonquantitative) Test System
More FDA Info for this Device
510(K) Number
K080851
Device Name
Urinary Homocystine (Nonquantitative) Test System
Applicant
ANTICANCER INC
7917 OSTROW ST.
SAN DIEGO, CA 92111 US
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Contact
YUYING TAN
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
03/26/2008
Decision Date
10/10/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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