Device Classification Name |
Reagent, Occult Blood
|
510(k) Number |
K080812 |
Device Name |
HEMOCCULT ICT |
Applicant |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 |
PO BOX 8000 |
BREA,
CA
92822
|
|
Applicant Contact |
SYLVIA ZORICH |
Correspondent |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 |
PO BOX 8000 |
BREA,
CA
92822
|
|
Correspondent Contact |
SYLVIA ZORICH |
Regulation Number | 864.6550
|
Classification Product Code |
|
Date Received | 03/24/2008 |
Decision Date | 06/25/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|