Device Classification Name |
electrolyte controls (assayed and unassayed)
|
510(k) Number |
K895582 |
Device Name |
QCLYTE PROTEIN-BASED ISE CONTROL |
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 | 862.1660
|
Classification Product Code |
|
Date Received | 09/15/1989 |
Decision Date | 10/04/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|