| Device Classification Name |
method, nephelometric, immunoglobulins (g, a, m)
|
|---|
| 510(K) Number |
K120750 |
|---|
| Model |
LK012.L.S.
|
| Device Name |
HUMAN IGM CSF KIT |
|---|
| Applicant |
| THE BINDING SITE GROUP LTD |
| 8 calthorpe road |
| edgbaston |
|
birmingham, west midlands,
|
|
| Contact |
jill constantine |
| Regulation Number | 866.5510
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 03/12/2012 |
|---|
| Decision Date | 05/17/2013 |
|---|
| Decision |
substantially equivalent - CLIA submission (CS) |
|---|
| Classification Advisory Committee |
Immunology
|
|---|
| Review Advisory Committee |
Immunology
|
|---|
| statement |
statement
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
