Device Classification Name |
radioimmunoassay, luteinizing hormone
|
510(k) Number |
K852376 |
Device Name |
SIMULTANEOUS LH/FSH SYSTEM BY RIA |
Applicant |
AMERICAN BIOCLINICAL, INC. |
P.O. BOX 12669 |
PORTLAND,
OR
97212
|
|
Applicant Contact |
JAN BALDWIN |
Correspondent |
AMERICAN BIOCLINICAL, INC. |
P.O. BOX 12669 |
PORTLAND,
OR
97212
|
|
Correspondent Contact |
JAN BALDWIN |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 06/04/1985 |
Decision Date | 07/09/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|