Device Classification Name |
Assay, Glycosylated Hemoglobin
|
510(k) Number |
K010748 |
Device Name |
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT |
Applicant |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 |
BREA,
CA
92822
|
|
Applicant Contact |
MARY BETH TANG |
Correspondent |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 |
BREA,
CA
92822
|
|
Correspondent Contact |
MARY BETH TANG |
Regulation Number | 864.7470
|
Classification Product Code |
|
Date Received | 03/13/2001 |
Decision Date | 07/10/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|