Device Classification Name |
Radioimmunoassay, Luteinizing Hormone
|
510(k) Number |
K896866 |
Device Name |
LUTEINIZING HORMONE-EIA-XT |
Applicant |
IN VITRO DIAGNOSTICS, INC. |
8100 SOUTHPARK WAY |
BLDG. B STE.1 |
LITTLETON,
CO
80120
|
|
Applicant Contact |
MUSICK, PH.D. |
Correspondent |
IN VITRO DIAGNOSTICS, INC. |
8100 SOUTHPARK WAY |
BLDG. B STE.1 |
LITTLETON,
CO
80120
|
|
Correspondent Contact |
MUSICK, PH.D. |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 12/06/1989 |
Decision Date | 02/13/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|