Device Classification Name |
tetraphenyl borate, colorimetry, potassium
|
510(k) Number |
K043267 |
Device Name |
POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 |
Applicant |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. |
CRUMLIN, COUNTY ANTRIM,
GB
BT29 4QY
|
|
Applicant Contact |
P. ARMSTRONG |
Correspondent |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. |
CRUMLIN, COUNTY ANTRIM,
GB
BT29 4QY
|
|
Correspondent Contact |
P. ARMSTRONG |
Regulation Number | 862.1600
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/26/2004 |
Decision Date | 02/10/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|