Device Classification Name |
Radioimmunoassay, Free Thyroxine
|
510(k) Number |
K980819 |
Device Name |
BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS |
Applicant |
BIOCIRCUITS CORP. |
1324 CHESAPEAKE TERR. |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
SHEILA J RAMERMAN |
Correspondent |
BIOCIRCUITS CORP. |
1324 CHESAPEAKE TERR. |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
SHEILA J RAMERMAN |
Regulation Number | 862.1695
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/03/1998 |
Decision Date | 04/03/1998 |
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
|
|
|