Device Classification Name |
radioassay, vitamin b12
|
510(k) Number |
K110413 |
Device Name |
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS |
Applicant |
BECKMAN COULTER, INC. |
250 SOUTH KRAEMER BLVD |
BREA,
CA
92822
|
|
Applicant Contact |
MARINE BOYAJIAN |
Correspondent |
BECKMAN COULTER, INC. |
250 SOUTH KRAEMER BLVD |
BREA,
CA
92822
|
|
Correspondent Contact |
MARINE BOYAJIAN |
Regulation Number | 862.1810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/14/2011 |
Decision Date | 05/11/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|