Device Classification Name |
Radioimmunoassay, Free Thyroxine
|
510(k) Number |
K030329 |
Device Name |
FASTPACK FREE T4 IMMUNOASSAY |
Applicant |
Qualigen, Inc. |
2042 CORTE DEL NOGAL |
CARLSBAD,
CA
92009 -1410
|
|
Applicant Contact |
DOROTHY DEINZER |
Correspondent |
Qualigen, Inc. |
2042 CORTE DEL NOGAL |
CARLSBAD,
CA
92009 -1410
|
|
Correspondent Contact |
DOROTHY DEINZER |
Regulation Number | 862.1695
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/31/2003 |
Decision Date | 07/03/2003 |
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
|
|
|