Device Classification Name |
Radioimmunoassay, Immunoreactive Insulin
|
510(k) Number |
K953084 |
Device Name |
ACCESS ULTRASENSITIVE INSULIN ASSAY |
Applicant |
BIO-RAD LABORATORIES, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Applicant Contact |
DENNIS GRIFFIN |
Correspondent |
BIO-RAD LABORATORIES, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Correspondent Contact |
DENNIS GRIFFIN |
Regulation Number | 862.1405
|
Classification Product Code |
|
Date Received | 07/03/1995 |
Decision Date | 09/25/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|