Device Classification Name |
Myoglobin, Antigen, Antiserum, Control
|
510(k) Number |
K983848 |
Device Name |
ABBOTT AXSYM MYOGLOBIN |
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 | 866.5680
|
Classification Product Code |
|
Date Received | 10/30/1998 |
Decision Date | 11/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|