Device Classification Name |
glucose oxidase, glucose
|
510(k) Number |
K972473 |
Device Name |
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK |
Applicant |
LIFESCAN, INC. |
1000 GIBRALTAR DR. |
MILPITAS,
CA
95035 -6312
|
|
Applicant Contact |
JOHN E HUGHES |
Correspondent |
LIFESCAN, INC. |
1000 GIBRALTAR DR. |
MILPITAS,
CA
95035 -6312
|
|
Correspondent Contact |
JOHN E HUGHES |
Regulation Number | 862.1345
|
Classification Product Code |
|
Date Received | 07/01/1997 |
Decision Date | 12/16/1997 |
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
|
|
|