Device Classification Name |
assay, glycosylated hemoglobin
|
510(k) Number |
K001392 |
Device Name |
GLYCOSAL HBA1C TEST |
Applicant |
PROVALIS DIAGNOSTICS LTD. |
16809 BRIARDALE RD. |
ROCKVILLE,
MD
20855
|
|
Applicant Contact |
TOM TSAKERIS |
Correspondent |
PROVALIS DIAGNOSTICS LTD. |
16809 BRIARDALE RD. |
ROCKVILLE,
MD
20855
|
|
Correspondent Contact |
TOM TSAKERIS |
Regulation Number | 864.7470
|
Classification Product Code |
|
Date Received | 05/03/2000 |
Decision Date | 08/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|