Device Classification Name |
biuret (colorimetric), total protein
|
510(k) Number |
K971524 |
Device Name |
TOTAL PROTEIN OR TP |
Applicant |
CAROLINA LIQUID CHEMISTRIES CORP. |
451 WEST LAMBERT RD., |
SUITE 207 |
BREA,
CA
92821
|
|
Applicant Contact |
CYNTHIA SHUGART |
Correspondent |
CAROLINA LIQUID CHEMISTRIES CORP. |
451 WEST LAMBERT RD., |
SUITE 207 |
BREA,
CA
92821
|
|
Correspondent Contact |
CYNTHIA SHUGART |
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 04/28/1997 |
Decision Date | 05/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|