| Device Classification Name |
system, test, fibrin/fibrinogen degradation products for monitoring of colorectal cancer
|
|---|
| 510(k) Number |
K072901 |
|---|
| Device Name |
AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101 |
|---|
| Applicant |
| AMDL, INC. |
| 2492 WALNUT AVE. SUITE 100 |
|
TUSTIN,
CA
92780 -7039
|
|
| Applicant Contact |
GARY DREHER |
| Correspondent |
| AMDL, INC. |
| 2492 WALNUT AVE. SUITE 100 |
|
TUSTIN,
CA
92780 -7039
|
|
| Correspondent Contact |
GARY DREHER |
| Regulation Number | 866.6010
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 10/11/2007 |
|---|
| Decision Date | 07/01/2008 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Immunology
|
|---|
| 510k Review Panel |
Immunology
|
|---|
| Summary |
Summary
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|