Device Classification Name |
Susceptibility Test Discs, Antimicrobial
|
510(k) Number |
K874425 |
Device Name |
CIPROFLOXACIN 5 MCG SENSI-DISC |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Applicant Contact |
J ARNSBERGER |
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
1 BECTON DR. |
FRANKLIN LAKES,
NJ
07417 -1880
|
|
Correspondent Contact |
J ARNSBERGER |
Regulation Number | 866.1620
|
Classification Product Code |
|
Date Received | 10/28/1987 |
Decision Date | 11/20/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|