Device Classification Name |
electrode, ion specific, potassium
|
510(k) Number |
K896692 |
Device Name |
AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER |
Applicant |
BAXTER HEALTHCARE CORP. |
P.O. BOX 25101 |
SANTA ANA,
CA
92799
|
|
Applicant Contact |
KRISTA U SMALLEY |
Correspondent |
BAXTER HEALTHCARE CORP. |
P.O. BOX 25101 |
SANTA ANA,
CA
92799
|
|
Correspondent Contact |
KRISTA U SMALLEY |
Regulation Number | 862.1600
|
Classification Product Code |
|
Date Received | 11/28/1989 |
Decision Date | 01/02/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|