Device Classification Name |
flask, tissue culture
|
510(k) Number |
K972404 |
Device Name |
VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
ONE BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
JOHN SCHALAGO |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
ONE BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
JOHN SCHALAGO |
Regulation Number | 864.2240
|
Classification Product Code |
|
Date Received | 06/26/1997 |
Decision Date | 07/22/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|