Device Classification Name |
radioimmunoassay, luteinizing hormone
|
510(k) Number |
K860538 |
Device Name |
RIGHT-DAY URINARY LH (EIA) |
Applicant |
LEECO DIAGNOSTICS, INC. |
21705 EVERGREEN |
P.O. BOX 5126 |
SOUTHFIELD,
MI
48075
|
|
Applicant Contact |
LEE, PH.D. |
Correspondent |
LEECO DIAGNOSTICS, INC. |
21705 EVERGREEN |
P.O. BOX 5126 |
SOUTHFIELD,
MI
48075
|
|
Correspondent Contact |
LEE, PH.D. |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 02/12/1986 |
Decision Date | 07/29/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|