Device Classification Name |
calibrator, primary
|
510(k) Number |
K010696 |
Device Name |
BECKMAN COULTER DNASE B CALIBRATOR |
Applicant |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 |
BREA,
CA
92822
|
|
Applicant Contact |
RICHARD T ROSS |
Correspondent |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. W-110 |
BREA,
CA
92822
|
|
Correspondent Contact |
RICHARD T ROSS |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 03/08/2001 |
Decision Date | 05/10/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|