Device Classification Name |
system, test, thyroid autoantibody
|
510(k) Number |
K981521 |
Device Name |
AIA-PACK TPOAB ASSAY |
Applicant |
TOSOH MEDICS, INC. |
373 VINTAGE PARK DR. |
SUITE D |
FOSTER CITY,
CA
94404
|
|
Applicant Contact |
LON ROBINSON |
Correspondent |
TOSOH MEDICS, INC. |
373 VINTAGE PARK DR. |
SUITE D |
FOSTER CITY,
CA
94404
|
|
Correspondent Contact |
LON ROBINSON |
Regulation Number | 866.5870
|
Classification Product Code |
|
Date Received | 04/28/1998 |
Decision Date | 10/08/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|