| Device Classification Name |
21-hydroxylase antibody (21-ohab)
|
|---|
| 510(K) Number |
K121046 |
|---|
| Device Name |
STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT |
|---|
| Applicant |
| KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
| 170 s. seneca springs way |
| suite 105 |
|
star,
ID
83669
|
|
| Contact |
heather viele |
| Regulation Number | 866.5660
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/06/2012 |
|---|
| Decision Date | 12/20/2012 |
|---|
| Decision |
substantially equivalent - CLIA submission (CS) |
|---|
| Classification Advisory Committee |
Immunology
|
|---|
| Review Advisory Committee |
Immunology
|
|---|
| summary |
summary
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
