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FDA 510(k) Application Details - K052788
Device Classification Name
Urinary Homocystine (Nonquantitative) Test System
More FDA Info for this Device
510(K) Number
K052788
Device Name
Urinary Homocystine (Nonquantitative) Test System
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
GLASGOW BLDG. 500
NEWARK, DE 19714-6101 US
Other 510(k) Applications for this Company
Contact
KATHLEEN A DRAY-LYONS
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
10/03/2005
Decision Date
03/29/2006
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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