Device Classification Name |
acid, folic, radioimmunoassay
|
510(k) Number |
K023397 |
Device Name |
ABBOTT ARCHITECT FOLATE |
Applicant |
ABBOTT LABORATORIES |
200 ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -6187
|
|
Applicant Contact |
MARGARET PROCHNIAK |
Correspondent |
ABBOTT LABORATORIES |
200 ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -6187
|
|
Correspondent Contact |
MARGARET PROCHNIAK |
Regulation Number | 862.1295
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/09/2002 |
Decision Date | 12/16/2002 |
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
|
|
|