Device Classification Name |
Tubes, Vials, Systems, Serum Separators, Blood Collection
|
510(k) Number |
K980414 |
Device Name |
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
JOHN SCHALAGO |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
JOHN SCHALAGO |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 02/03/1998 |
Decision Date | 03/03/1998 |
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
|
|
|