Device Classification Name |
Photometric Method, Magnesium
|
510(k) Number |
K122302 |
Device Name |
ACE MAGNESIUM REGENT |
Applicant |
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC |
4 HENDERSON DRIVE |
WEST CALDWELL,
NJ
07006
|
|
Applicant Contact |
HYMAN KATZ |
Correspondent |
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC |
4 HENDERSON DRIVE |
WEST CALDWELL,
NJ
07006
|
|
Correspondent Contact |
HYMAN KATZ |
Regulation Number | 862.1495
|
Classification Product Code |
|
Date Received | 08/01/2012 |
Decision Date | 08/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|