Device Classification Name |
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
|
510(k) Number |
K870776 |
Device Name |
RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT |
Applicant |
REAGENTS APPLICATIONS, INC. |
8225 MERCURY CT. |
SAN DIEGO,
CA
92111 -1203
|
|
Applicant Contact |
ALFRED E PEACOCK,JR |
Correspondent |
REAGENTS APPLICATIONS, INC. |
8225 MERCURY CT. |
SAN DIEGO,
CA
92111 -1203
|
|
Correspondent Contact |
ALFRED E PEACOCK,JR |
Regulation Number | 862.1580
|
Classification Product Code |
|
Date Received | 02/26/1987 |
Decision Date | 03/13/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|