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FDA 510(k) Application Details - K060755
Device Classification Name
Radioassay, Vitamin B12
More FDA Info for this Device
510(K) Number
K060755
Device Name
Radioassay, Vitamin B12
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50416
INDIANAPOLIS, IN 46250-0457 US
Other 510(k) Applications for this Company
Contact
RANDY J JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
862.1810
More FDA Info for this Regulation Number
Classification Product Code
CDD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/21/2006
Decision Date
04/10/2006
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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