Device Classification Name |
resins, ion-exchange
|
510(k) Number |
K833320 |
Device Name |
AMBERLITE CG50 RESIN, 100-200 MESH |
Applicant |
BIOSAN LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BIOSAN LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.2230
|
Classification Product Code |
|
Date Received | 09/26/1983 |
Decision Date | 12/08/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Pathology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|