Device Classification Name |
antibodies, anti-cyclic citrullinated peptide (ccp)
|
510(k) Number |
K061165 |
Device Name |
ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 |
Applicant |
SWEDEN DIAGNOSTICS (US), INC. |
4169 COMMERCIAL AVE. |
PORTAGE,
MI
49002
|
|
Applicant Contact |
MARTIN R MANN |
Correspondent |
SWEDEN DIAGNOSTICS (US), INC. |
4169 COMMERCIAL AVE. |
PORTAGE,
MI
49002
|
|
Correspondent Contact |
MARTIN R MANN |
Regulation Number | 866.5775
|
Classification Product Code |
|
Date Received | 04/26/2006 |
Decision Date | 08/03/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|