Device Classification Name |
Radioimmunoassay, Parathyroid Hormone
|
510(k) Number |
K861797 |
Device Name |
ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY |
Applicant |
NICHOLS INSTITUTE DIAGNOSTICS |
P.O. BOX 92797 |
LOS ANGELES,
CA
90009
|
|
Applicant Contact |
ELAINE WALTON |
Correspondent |
NICHOLS INSTITUTE DIAGNOSTICS |
P.O. BOX 92797 |
LOS ANGELES,
CA
90009
|
|
Correspondent Contact |
ELAINE WALTON |
Regulation Number | 862.1545
|
Classification Product Code |
|
Date Received | 05/09/1986 |
Decision Date | 07/22/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|