Device Classification Name |
Glucose Oxidase, Glucose
|
510(k) Number |
K982076 |
Device Name |
AMIRA MEDICAL ATLAST BLOOD GLUCOSE MONITORING SYSTEM |
Applicant |
AMIRA MEDICAL, INC. |
4742 SCOTTS VALLEY DR. |
SCOTTS VALLEY,
CA
95066
|
|
Applicant Contact |
DAVID A HASKER |
Correspondent |
AMIRA MEDICAL, INC. |
4742 SCOTTS VALLEY DR. |
SCOTTS VALLEY,
CA
95066
|
|
Correspondent Contact |
DAVID A HASKER |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 06/12/1998 |
Decision Date | 12/10/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|