Device Classification Name |
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
|
510(k) Number |
K770456 |
Device Name |
PHOSPHOROUS, INORGANIC, TEKPOINT DIRECT |
Applicant |
ICN PHARMACEUTICALS, INC. |
13 MOUNTAINVIEW AVE. |
ORANGEBURG,
NY
10962
|
|
Correspondent |
ICN PHARMACEUTICALS, INC. |
13 MOUNTAINVIEW AVE. |
ORANGEBURG,
NY
10962
|
|
Regulation Number | 862.1580
|
Classification Product Code |
|
Date Received | 03/08/1977 |
Decision Date | 05/03/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|