Device Classification Name |
radioimmunoassay, luteinizing hormone
|
510(k) Number |
K900621 |
Device Name |
FIAGEN(TM) HLH.S |
Applicant |
CYBERFLUOR, INC. |
179 JOHN ST., 4TH FL., |
TORONTO |
ONTARIO M5T 1X4,
CA
|
|
Applicant Contact |
JAMES CLELLAND |
Correspondent |
CYBERFLUOR, INC. |
179 JOHN ST., 4TH FL., |
TORONTO |
ONTARIO M5T 1X4,
CA
|
|
Correspondent Contact |
JAMES CLELLAND |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 02/08/1990 |
Decision Date | 03/01/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|