Device Classification Name |
culture media, antimicrobial susceptibility test, excluding mueller hinton agar
|
510(k) Number |
K160512 |
Device Name |
HardyCHROM ESBL |
Applicant |
HARDY DIAGNOSTICS |
1430 WEST MCCOU LANE |
SANTA MARIA,
CA
93455
|
|
Applicant Contact |
ANDRE HSIUNG |
Correspondent |
HARDY DIAGNOSTICS |
1430 WEST MCCOU LANE |
SANTA MARIA,
CA
93455
|
|
Correspondent Contact |
ANDRE HSIUNG |
Regulation Number | 866.1700
|
Classification Product Code |
|
Date Received | 02/24/2016 |
Decision Date | 11/15/2016 |
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
|
|
|