Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K162538
Device Classification Name
Calibrator, Secondary
More FDA Info for this Device
510(K) Number
K162538
Device Name
Calibrator, Secondary
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
333 CONEY STREET
E. WALPOLE, MA 02032 US
Other 510(k) Applications for this Company
Contact
SUSAN FERRIN
Other 510(k) Applications for this Contact
Regulation Number
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/12/2016
Decision Date
11/17/2016
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact