Device Classification Name |
radioimmunoassay, luteinizing hormone
|
510(k) Number |
K863442 |
Device Name |
UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE |
Applicant |
UNITED BIOTECH, INC. |
1300C SPACEPARK WAY |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
JOSEPH FU |
Correspondent |
UNITED BIOTECH, INC. |
1300C SPACEPARK WAY |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
JOSEPH FU |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 09/05/1986 |
Decision Date | 02/04/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|