Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
510(k) Number |
K112603 |
Device Name |
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS |
Applicant |
BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Applicant Contact |
CINDY MCGUIRE |
Correspondent |
BECKMAN COULTER, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Correspondent Contact |
CINDY MCGUIRE |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 09/07/2011 |
Decision Date | 11/04/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|