Device Classification Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection
|
510(k) Number |
K030573 |
Device Name |
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 |
Applicant |
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS |
1 BECTON DR., BECTON BLDG. |
FRANKLIN LAKES,
NJ
07417 -1885
|
|
Applicant Contact |
M. WENDY BALLESTEROS |
Correspondent |
BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS |
1 BECTON DR., BECTON BLDG. |
FRANKLIN LAKES,
NJ
07417 -1885
|
|
Correspondent Contact |
M. WENDY BALLESTEROS |
Regulation Number | 862.1675
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/24/2003 |
Decision Date | 05/08/2003 |
Decision |
Substantially Equivalent
(SESE) |
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
|
|
|