Device Classification Name |
radioassay, vitamin b12
|
510(k) Number |
K090588 |
Device Name |
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 |
Applicant |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. |
BREA,
CA
92821
|
|
Applicant Contact |
MARY B TANG |
Correspondent |
BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. |
BREA,
CA
92821
|
|
Correspondent Contact |
MARY B TANG |
Regulation Number | 862.1810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/04/2009 |
Decision Date | 05/27/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|