Device Classification Name |
tubes, vials, systems, serum separators, blood collection
|
510(k) Number |
K931367 |
Device Name |
VACUTAINER BRAND LUER ADAPTER |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
RUSSELL ARNSBERGER |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
RUSSELL ARNSBERGER |
Regulation Number | 862.1675
|
Classification Product Code |
|
Date Received | 03/17/1993 |
Decision Date | 05/11/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|