Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K153692 |
Device Name |
Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer |
Applicant |
INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) |
17408 TILLER COURT SUITE 1900 |
WESTFIELD,
IN
40674
|
|
Applicant Contact |
JULIE PASCHAL |
Correspondent |
INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED) |
17408 TILLER COURT SUITE 1900 |
WESTFIELD,
IN
40674
|
|
Correspondent Contact |
JULIE PASCHAL |
Regulation Number | 862.1345
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/23/2015 |
Decision Date | 06/24/2016 |
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
|
|
|