Device Classification Name |
Acid, Folic, Radioimmunoassay
|
510(k) Number |
K972232 |
Device Name |
ABBOTT AXSYM FOLATE |
Applicant |
ABBOTT LABORATORIES |
200 ABBOTT PARK RD. |
ABBOTT PARK,,
IL
60064 -3537
|
|
Applicant Contact |
LAURA L GRANITZ |
Correspondent |
ABBOTT LABORATORIES |
200 ABBOTT PARK RD. |
ABBOTT PARK,,
IL
60064 -3537
|
|
Correspondent Contact |
LAURA L GRANITZ |
Regulation Number | 862.1295
|
Classification Product Code |
|
Date Received | 06/16/1997 |
Decision Date | 06/24/1997 |
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
|
|
|