Device Classification Name |
Radioimmunoassay, Luteinizing Hormone
|
510(k) Number |
K864144 |
Device Name |
LUTEINIZING HORMONE (LH-IRMA) RIA KIT |
Applicant |
IMMUCHEM CORP. |
P.O. BOX 6227 |
2015 EAST UNIVERSITY DRIVE |
CARSON,
CA
90746
|
|
Applicant Contact |
BURNS, PHD |
Correspondent |
IMMUCHEM CORP. |
P.O. BOX 6227 |
2015 EAST UNIVERSITY DRIVE |
CARSON,
CA
90746
|
|
Correspondent Contact |
BURNS, PHD |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 10/22/1986 |
Decision Date | 11/24/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|