Device Classification Name |
biuret (colorimetric), total protein
|
510(k) Number |
K851877 |
Device Name |
TOTAL PROTEIN LIQUID STABLE REAGENT SET |
Applicant |
MEDICAL ANALYSIS SYSTEMS, INC. |
LINCOLN TECHNOLOGY PARK |
542 FLYNN RD. |
CAMARILLO,
CA
93012
|
|
Applicant Contact |
DONNA L ANDERSON |
Correspondent |
MEDICAL ANALYSIS SYSTEMS, INC. |
LINCOLN TECHNOLOGY PARK |
542 FLYNN RD. |
CAMARILLO,
CA
93012
|
|
Correspondent Contact |
DONNA L ANDERSON |
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 04/29/1985 |
Decision Date | 05/20/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|