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FDA 510(k) Application Details - K011689
Device Classification Name
Urinary Homocystine (Nonquantitative) Test System
More FDA Info for this Device
510(K) Number
K011689
Device Name
Urinary Homocystine (Nonquantitative) Test System
Applicant
CATCH, INC.
PO BOX 2219
LONGVIEW, WA 98632 US
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Contact
MARK E LEGAZ
Other 510(k) Applications for this Contact
Regulation Number
862.1377
More FDA Info for this Regulation Number
Classification Product Code
LPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/31/2001
Decision Date
07/25/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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