Device Classification Name |
phosphomolybdate (colorimetric), inorganic phosphorus
|
510(k) Number |
K945368 |
Device Name |
PHOSPHORUS TEST (PHOS) |
Applicant |
EMD CHEMICALS INC. |
DIV. OF EM INDUSTRIES INC. |
480 DEMOCRAT RD. |
GIBBSTOWN,
NJ
08027
|
|
Applicant Contact |
CAROL FAULKNER |
Correspondent |
EMD CHEMICALS INC. |
DIV. OF EM INDUSTRIES INC. |
480 DEMOCRAT RD. |
GIBBSTOWN,
NJ
08027
|
|
Correspondent Contact |
CAROL FAULKNER |
Regulation Number | 862.1580
|
Classification Product Code |
|
Date Received | 10/20/1994 |
Decision Date | 12/02/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|