Device Classification Name |
Biuret (Colorimetric), Total Protein
|
510(k) Number |
K980042 |
Device Name |
CARESIDE TOTAL PROTEIN |
Applicant |
EXIGENT DIAGNOSTICS, INC. |
6100 BRISTOL PKWY. |
CULVER CITY,
CA
90230
|
|
Applicant Contact |
KENNETH B ASARCH |
Correspondent |
EXIGENT DIAGNOSTICS, INC. |
6100 BRISTOL PKWY. |
CULVER CITY,
CA
90230
|
|
Correspondent Contact |
KENNETH B ASARCH |
Regulation Number | 862.1635
|
Classification Product Code |
|
Date Received | 01/06/1998 |
Decision Date | 02/04/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|