Device Classification Name |
system, test, radioallergosorbent (rast) immunological
|
510(k) Number |
K131738 |
Device Name |
IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H |
Applicant |
PHADIA AB |
RAPSGATAN 7 |
P.O. BOX 6460 |
UPPSALA,
SE
SE - 75137
|
|
Applicant Contact |
CARINA MAGNUSSON |
Correspondent |
PHADIA AB |
RAPSGATAN 7 |
P.O. BOX 6460 |
UPPSALA,
SE
SE - 75137
|
|
Correspondent Contact |
CARINA MAGNUSSON |
Regulation Number | 866.5750
|
Classification Product Code |
|
Date Received | 06/13/2013 |
Decision Date | 07/10/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|