Device Classification Name |
Radioimmunoassay, Luteinizing Hormone
|
510(k) Number |
K991386 |
Device Name |
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) |
Applicant |
SELFCARE, INC. |
200 PROSPECT ST. |
WALTHAM,
MA
02154 -3457
|
|
Applicant Contact |
Carol Adiletto |
Correspondent |
SELFCARE, INC. |
200 PROSPECT ST. |
WALTHAM,
MA
02154 -3457
|
|
Correspondent Contact |
Carol Adiletto |
Regulation Number | 862.1485
|
Classification Product Code |
|
Date Received | 04/21/1999 |
Decision Date | 05/25/1999 |
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
|
|
|