Device Classification Name |
Radioimmunoassay, Luteinizing Hormone
|
510(k) Number |
K903052 |
Device Name |
IMMUNOCORP LH IRMA COATED TUBE |
Applicant |
IMMUNOCORP SCIENCES, INC. |
5800 ROYALMOUNT |
MONTREAL (QUEBEC),
CA
H4P 1K5
|
|
Correspondent |
IMMUNOCORP SCIENCES, INC. |
5800 ROYALMOUNT |
MONTREAL (QUEBEC),
CA
H4P 1K5
|
|
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 07/11/1990 |
Decision Date | 08/29/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|