Device Classification Name |
coulometric, chloride
|
510(k) Number |
K121823 |
Device Name |
CLINICAL CHLORIDE ANALYZER, CHLORIDE TEST SYSTEM, SWEAT CHLORIDE ANALYZER, CHLORIDOMETER, CHLORIDE COULOMETRIC |
Applicant |
WESCOR, INC. |
370 West 1700 South |
Logan,
UT
84321
|
|
Applicant Contact |
DAWN T PERDUE |
Correspondent |
WESCOR, INC. |
370 West 1700 South |
Logan,
UT
84321
|
|
Correspondent Contact |
DAWN T PERDUE |
Regulation Number | 862.1170
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/21/2012 |
Decision Date | 03/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|