Device Classification Name |
radioimmunoassay, luteinizing hormone
|
510(k) Number |
K921176 |
Device Name |
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM |
Applicant |
VITEK SYSTEMS, INC. |
595 ANGLUM DR. |
HAZELWOOD,
MI
63042 -2395
|
|
Applicant Contact |
WINTERS HEARD |
Correspondent |
VITEK SYSTEMS, INC. |
595 ANGLUM DR. |
HAZELWOOD,
MI
63042 -2395
|
|
Correspondent Contact |
WINTERS HEARD |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 03/11/1992 |
Decision Date | 04/08/1992 |
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
|
|
|