Device Classification Name |
radioimmunoassay, parathyroid hormone
|
510(k) Number |
K782010 |
Device Name |
HORMONE KIT, PARATHYROID |
Applicant |
NICHOLS INSTITUTE DIAGNOSTICS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
NICHOLS INSTITUTE DIAGNOSTICS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1545
|
Classification Product Code |
|
Date Received | 12/01/1978 |
Decision Date | 01/10/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|