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FDA 510(k) Application Details - K172992
Device Classification Name
System, Test, Vitamin D
More FDA Info for this Device
510(K) Number
K172992
Device Name
System, Test, Vitamin D
Applicant
Diazyme Laboratories
12889 Gregg Court
Poway, CA 92130 US
Other 510(k) Applications for this Company
Contact
Abhijit Datta
Other 510(k) Applications for this Contact
Regulation Number
862.1825
More FDA Info for this Regulation Number
Classification Product Code
MRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/27/2017
Decision Date
01/11/2018
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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