Device Classification Name |
immunoassay method, troponin subunit
|
510(k) Number |
K984359 |
Device Name |
AIA-PACK TROPONIN I ASSAY |
Applicant |
TOSOH MEDICS, INC. |
347 OYSTER POINT BLVD., |
SUITE 201 |
SAN FRANCISCO,
CA
94080
|
|
Applicant Contact |
LORI ROBINSON |
Correspondent |
TOSOH MEDICS, INC. |
347 OYSTER POINT BLVD., |
SUITE 201 |
SAN FRANCISCO,
CA
94080
|
|
Correspondent Contact |
LORI ROBINSON |
Regulation Number | 862.1215
|
Classification Product Code |
|
Date Received | 12/07/1998 |
Decision Date | 12/23/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|