Device Classification Name |
phosphomolybdate (colorimetric), inorganic phosphorus
|
510(k) Number |
K862834 |
Device Name |
MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT |
Applicant |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
16 FIRST ST. |
WEST ROYALTY INDUSTRIAL PARK |
CHARLOTTESTOWN,PEI,CANADA,
CA
C1E 1B0
|
|
Applicant Contact |
CALLBECK, R.T. |
Correspondent |
DIAGNOSTIC CHEMICALS, LTD. (USA) |
16 FIRST ST. |
WEST ROYALTY INDUSTRIAL PARK |
CHARLOTTESTOWN,PEI,CANADA,
CA
C1E 1B0
|
|
Correspondent Contact |
CALLBECK, R.T. |
Regulation Number | 862.1580
|
Classification Product Code |
|
Date Received | 07/25/1986 |
Decision Date | 08/19/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|