Device Classification Name |
Acid, Folic, Radioimmunoassay
|
510(k) Number |
K010050 |
Device Name |
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY |
Applicant |
BAYER DIAGNOSTICS CORP. |
63 NORTH ST. |
MEDFIELD,
MA
02052
|
|
Applicant Contact |
THOMAS F FLYNN |
Correspondent |
BAYER DIAGNOSTICS CORP. |
63 NORTH ST. |
MEDFIELD,
MA
02052
|
|
Correspondent Contact |
THOMAS F FLYNN |
Regulation Number | 862.1295
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/05/2001 |
Decision Date | 02/05/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|