| Device Classification Name |
Susceptibility Test Powders, Antimycobacterial
|
|---|
| 510(k) Number |
K972772 |
|---|
| Device Name |
ESP CULTURE SYSTEM II - MYCO SUSCEPTIBILITY TESTING |
|---|
| Applicant |
| Trek Diagnostic Systems, Inc. |
| 29299 Clemens Rd. Suite 1-K |
|
Westlake,
OH
44145
|
|
| Applicant Contact |
NADINE SULLIVAN |
| Correspondent |
| Trek Diagnostic Systems, Inc. |
| 29299 Clemens Rd. Suite 1-K |
|
Westlake,
OH
44145
|
|
| Correspondent Contact |
NADINE SULLIVAN |
| Regulation Number | 866.1640 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/24/1997 |
|---|
| Decision Date | 07/13/1999 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Microbiology
|
|---|
| 510k Review Panel |
Microbiology
|
|---|
| Statement |
Statement
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|