Device Classification Name |
phosphomolybdate (colorimetric), inorganic phosphorus
|
510(k) Number |
K974605 |
Device Name |
RANDOX INORGANIC PHOSPHOROUS |
Applicant |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. |
CRUMLIN, CO. ANTRIM,
IE
BT29 4QY
|
|
Applicant Contact |
P. ARMSTRONG |
Correspondent |
RANDOX LABORATORIES, LTD. |
55 DIAMOND RD. |
CRUMLIN, CO. ANTRIM,
IE
BT29 4QY
|
|
Correspondent Contact |
P. ARMSTRONG |
Regulation Number | 862.1580
|
Classification Product Code |
|
Date Received | 12/10/1997 |
Decision Date | 01/09/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|