Device Classification Name |
assay, glycosylated hemoglobin
|
510(k) Number |
K100304 |
Device Name |
ST AIA PACK HBA1C |
Applicant |
Tosoh BioScience, Inc. |
6000 SHORELINE COURT |
SUITE 101 |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Applicant Contact |
Judith Ogden |
Correspondent |
Tosoh BioScience, Inc. |
6000 SHORELINE COURT |
SUITE 101 |
SOUTH SAN FRANCISCO,
CA
94080
|
|
Correspondent Contact |
Judith Ogden |
Regulation Number | 864.7470
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/03/2010 |
Decision Date | 08/27/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|