Device Classification Name |
system, test, radioallergosorbent (rast) immunological
|
510(k) Number |
K993388 |
Device Name |
ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F |
Applicant |
PHARMACIA & UPJOHN CO. |
5094 ST. ANDREWS DR. |
WESTERVILLLE,
OH
43082
|
|
Applicant Contact |
KAREN E MATIS |
Correspondent |
PHARMACIA & UPJOHN CO. |
5094 ST. ANDREWS DR. |
WESTERVILLLE,
OH
43082
|
|
Correspondent Contact |
KAREN E MATIS |
Regulation Number | 866.5750
|
Classification Product Code |
|
Date Received | 10/08/1999 |
Decision Date | 12/01/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|