Device Classification Name |
fluorometer, for clinical use
|
510(k) Number |
K971103 |
Device Name |
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM |
Applicant |
TOSOH MEDICS, INC. |
373 VINTAGE PARK DR. |
SUITE D |
FOSTER CITY,
CA
94404
|
|
Applicant Contact |
LORI ROBINSON |
Correspondent |
TOSOH MEDICS, INC. |
373 VINTAGE PARK DR. |
SUITE D |
FOSTER CITY,
CA
94404
|
|
Correspondent Contact |
LORI ROBINSON |
Regulation Number | 862.2560
|
Classification Product Code |
|
Date Received | 03/26/1997 |
Decision Date | 06/27/1997 |
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
|
Recalls |
CDRH Recalls
|
|
|