| Device Classification Name |
anti-phospholipase a2 receptor
|
|---|
| 510(k) Number |
K132195 |
|---|
| Device Name |
EUROIMMUN ANTI-PLA2R ELISA (IGG) |
|---|
| Applicant |
| EUROIMMUN US INC |
| 1100 THE AMERICAN ROAD |
|
MORRIS PLAINS,
NJ
07950
|
|
| Applicant Contact |
MICHAEL LOCKE |
| Correspondent |
| EUROIMMUN US INC |
| 1100 THE AMERICAN ROAD |
|
MORRIS PLAINS,
NJ
07950
|
|
| Correspondent Contact |
MICHAEL LOCKE |
| Regulation Number | 866.5780
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/15/2013 |
|---|
| Decision Date | 06/27/2014 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Microbiology
|
|---|
| 510k Review Panel |
Immunology
|
|---|
| Summary |
Summary
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|