Device Classification Name |
hexokinase, glucose
|
510(k) Number |
K123018 |
Device Name |
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE |
Applicant |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE |
WEST CALDWELL,
NJ
07006
|
|
Applicant Contact |
HYMAN KATZ PH.D. |
Correspondent |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE |
WEST CALDWELL,
NJ
07006
|
|
Correspondent Contact |
HYMAN KATZ PH.D. |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/28/2012 |
Decision Date | 04/23/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|