Device Classification Name |
Electrophoretic, Lactate Dehydrogenase Isoenzymes
|
510(k) Number |
K100307 |
Device Name |
GELSCAN, MODEL 1206 |
Applicant |
SEBIA |
1705 CORPORATE DRIVE |
SUITE 400 |
NORCROSS,
GA
30093
|
|
Applicant Contact |
KAREN ANDERSON |
Correspondent |
SEBIA |
1705 CORPORATE DRIVE |
SUITE 400 |
NORCROSS,
GA
30093
|
|
Correspondent Contact |
KAREN ANDERSON |
Regulation Number | 862.1445
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/03/2010 |
Decision Date | 08/31/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|