Device Classification Name |
colorimetry, cholinesterase
|
510(k) Number |
K002792 |
Device Name |
CARESIDE CHOLINESTERASE |
Applicant |
CARESIDE, INC. |
6100 BRISTOL PKWY. |
CULVER CITY,
CA
90230
|
|
Applicant Contact |
KENNETH B ASARCH |
Correspondent |
CARESIDE, INC. |
6100 BRISTOL PKWY. |
CULVER CITY,
CA
90230
|
|
Correspondent Contact |
KENNETH B ASARCH |
Regulation Number | 862.3240
|
Classification Product Code |
|
Date Received | 09/07/2000 |
Decision Date | 11/08/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|