| Device Classification Name |
assay, glycosylated hemoglobin
|
|---|
| 510(K) Number |
K122101 |
|---|
| Models |
1227,
2015,
4744,
4755
|
| Device Name |
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C |
|---|
| Applicant |
| SEBIA |
| 1705 corporate drive |
| suite 400 |
|
duluth,
GA
30093
|
|
| Contact |
karen anderson |
| Regulation Number | 864.7470
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Codes |
|
|---|
| Date Received | 07/16/2012 |
|---|
| Decision Date | 12/06/2012 |
|---|
| Decision |
substantially equivalent - CLIA submission (CS) |
|---|
| Classification Advisory Committee |
Hematology
|
|---|
| Review Advisory Committee |
Clinical Chemistry
|
|---|
| summary |
summary
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
