Device Classification Name |
Radioimmunoassay, Luteinizing Hormone
|
510(k) Number |
K964925 |
Device Name |
SEALITE SCIENCES, INC. AQUALITE LH |
Applicant |
SEALITE SCIENCES, INC. |
3000 NORTHWOODS PKWY. |
NORCROSS,
GA
30071
|
|
Applicant Contact |
CATHRYN N CAMBRIA |
Correspondent |
SEALITE SCIENCES, INC. |
3000 NORTHWOODS PKWY. |
NORCROSS,
GA
30071
|
|
Correspondent Contact |
CATHRYN N CAMBRIA |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 12/09/1996 |
Decision Date | 01/22/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|