Device Classification Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection
|
510(k) Number |
K981013 |
FOIA Releasable 510(k) |
K981013
|
Device Name |
VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE |
Applicant |
BECTON DICKINSON VACUTAINER SYSTEMS |
ONE BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1885
|
|
Applicant Contact |
EILEEN SCHWEIGHARDT |
Correspondent |
BECTON DICKINSON VACUTAINER SYSTEMS |
ONE BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1885
|
|
Correspondent Contact |
EILEEN SCHWEIGHARDT |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 03/18/1998 |
Decision Date | 06/17/1998 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|