Device Classification Name |
Single (Specified) Analyte Controls (Assayed And Unassayed)
|
510(k) Number |
K971014 |
Device Name |
LIFESCAN SURESTEP PRO GLUCOSE CONTROL/LINEARITY SOLUTIONS |
Applicant |
LIFESCAN, INC. |
1000 GIBRALTAR DR. |
MILPITAS,
CA
95035 -6312
|
|
Applicant Contact |
JUDY MARTIN |
Correspondent |
LIFESCAN, INC. |
1000 GIBRALTAR DR. |
MILPITAS,
CA
95035 -6312
|
|
Correspondent Contact |
JUDY MARTIN |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 03/20/1997 |
Decision Date | 04/23/1997 |
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
|
|
|