Device Classification Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection
More FDA Info for this Device |
510(K) Number |
K133303 |
Device Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant |
BIO-ANALYSIS, INC.
27735 TAMARA DRIVE
YORBA LINDA, CA 92887 US
Other 510(k) Applications for this Company
|
Contact |
REGINA J O'MEARA
Other 510(k) Applications for this Contact |
Regulation Number |
862.1675
More FDA Info for this Regulation Number |
Classification Product Code |
JKA
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
10/25/2013 |
Decision Date |
11/19/2014 |
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 |
|