Device Classification Name |
Radioimmunoassay, Free Thyroxine
|
510(k) Number |
K982250 |
Device Name |
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
Applicant |
BECKMAN INSTRUMENTS, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Applicant Contact |
SHELLIE GUST |
Correspondent |
BECKMAN INSTRUMENTS, INC. |
1000 LAKE HAZELTINE DR. |
CHASKA,
MN
55318 -1084
|
|
Correspondent Contact |
SHELLIE GUST |
Regulation Number | 862.1695
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/26/1998 |
Decision Date | 07/14/1998 |
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
|
Recalls |
CDRH Recalls
|
|
|