Device Classification Name |
manual antimicrobial susceptibility test systems
|
510(k) Number |
K111429 |
Device Name |
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE... |
Applicant |
TREK DIAGNOSTIC SYSTEMS, LTD. |
982 KEYNOTE CIRCLE |
SUITE 6 |
CLEVELAND,
OH
44131
|
|
Applicant Contact |
CYNTHIA C KNAPP |
Correspondent |
TREK DIAGNOSTIC SYSTEMS, LTD. |
982 KEYNOTE CIRCLE |
SUITE 6 |
CLEVELAND,
OH
44131
|
|
Correspondent Contact |
CYNTHIA C KNAPP |
Regulation Number | 866.1640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/23/2011 |
Decision Date | 08/18/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|