Device Classification Name |
Hepatitis A Test (Antibody And Igm Antibody)
|
510(k) Number |
K113704 |
Device Name |
ARCHITECT HAVAB-G |
Applicant |
ABBOTT LABORATORIES |
100 ABBOTT PARK RD. |
DEPT. 09VA, BLDG. AP5 NORTH |
ABBOTT PARK,
IL
60064 -6092
|
|
Applicant Contact |
JUDITH WALLACH |
Correspondent |
ABBOTT LABORATORIES |
100 ABBOTT PARK RD. |
DEPT. 09VA, BLDG. AP5 NORTH |
ABBOTT PARK,
IL
60064 -6092
|
|
Correspondent Contact |
JUDITH WALLACH |
Regulation Number | 866.3310
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/16/2011 |
Decision Date | 06/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|