Device Classification Name |
radioimmunoassay, luteinizing hormone
|
510(k) Number |
K850480 |
Device Name |
OVU STICK SELF-TEST -MODIFICATION |
Applicant |
MONOCLONAL ANTIBODIES, INC. |
2319 CHARLESTON RD. |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
MICHAEL C MALONEY |
Correspondent |
MONOCLONAL ANTIBODIES, INC. |
2319 CHARLESTON RD. |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
MICHAEL C MALONEY |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 01/30/1985 |
Decision Date | 03/05/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|