Device Classification Name |
Culture Media, Selective And Non-Differential
|
510(k) Number |
K820060 |
Device Name |
CAMPYLOBACTER THIOGLYCOLLATE MED W/5 |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1875 EYE ST. NW STE. 625 |
WASHINGTON,
DC
20006
|
|
Regulation Number | 866.2360
|
Classification Product Code |
|
Date Received | 01/11/1982 |
Decision Date | 01/28/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|