Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
510(k) Number |
K894804 |
Device Name |
SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) |
Applicant |
LIFESCAN, INC. |
2443 WYANDOTTE ST. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
ROSEMARY D SELF |
Correspondent |
LIFESCAN, INC. |
2443 WYANDOTTE ST. |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
ROSEMARY D SELF |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 07/28/1989 |
Decision Date | 09/28/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|