Device Classification Name |
Single (Specified) Analyte Controls (Assayed And Unassayed)
|
510(k) Number |
K020217 |
Device Name |
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY |
Applicant |
BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591 -5097
|
|
Applicant Contact |
KENNETH T EDDS |
Correspondent |
BAYER DIAGNOSTICS CORP. |
511 BENEDICT AVE. |
TARRYTOWN,
NY
10591 -5097
|
|
Correspondent Contact |
KENNETH T EDDS |
Regulation Number | 862.1660
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/22/2002 |
Decision Date | 03/15/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|