Device Classification Name |
Susceptibility Test Discs, Antimicrobial
|
510(k) Number |
K964491 |
Device Name |
NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
Applicant |
UNIPATH LTD. |
15 OAK ST. |
BEVERLY FARMS,
MA
01915
|
|
Applicant Contact |
FRAN WHITE |
Correspondent |
UNIPATH LTD. |
15 OAK ST. |
BEVERLY FARMS,
MA
01915
|
|
Correspondent Contact |
FRAN WHITE |
Regulation Number | 866.1620
|
Classification Product Code |
|
Date Received | 11/07/1996 |
Decision Date | 02/07/1997 |
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
|
|
|