Device Classification Name |
system, transport, aerobic
|
510(k) Number |
K843341 |
Device Name |
GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK |
Applicant |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 866.2900
|
Classification Product Code |
|
Date Received | 08/27/1984 |
Decision Date | 09/27/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|