Device Classification Name |
Assay, Glycosylated Hemoglobin
|
510(k) Number |
K973696 |
Device Name |
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT |
Applicant |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 |
BOX 8000 |
BREA,
CA
92622 -8000
|
|
Applicant Contact |
LUCINDA STOCKERT |
Correspondent |
BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 |
BOX 8000 |
BREA,
CA
92622 -8000
|
|
Correspondent Contact |
LUCINDA STOCKERT |
Regulation Number | 864.7470
|
Classification Product Code |
|
Date Received | 09/26/1997 |
Decision Date | 11/24/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|