Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K133512
Device Classification Name
Radioassay, Vitamin B12
More FDA Info for this Device
510(K) Number
K133512
Device Name
Radioassay, Vitamin B12
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
500 GBC DRIVE
MS 514
NEWARK, DE 19702 US
Other 510(k) Applications for this Company
Contact
ANNA MARIE K ENNIS
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
11/15/2013
Decision Date
01/02/2014
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact