Device Classification Name |
Gbs Culture Media, Selective And Differential
|
510(k) Number |
K173903 |
Device Name |
Granada Medium |
Applicant |
Hardy Diagnostics |
1430 West McCoy Lane |
Santa Maria,
CA
93455
|
|
Applicant Contact |
Rianna Malherbe |
Correspondent |
Hardy Diagnostics |
1430 West McCoy Lane |
Santa Maria,
CA
93455
|
|
Correspondent Contact |
Rianna Malherbe |
Regulation Number | 866.2360
|
Classification Product Code |
|
Date Received | 12/22/2017 |
Decision Date | 03/22/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|