Device Classification Name |
Device, Fertility Diagnostic, Proceptive
|
510(k) Number |
K852801 |
Device Name |
BIOCHRON FERTILITY INDICATOR |
Applicant |
FERTIL-A-CHRON, INC. |
350 MOTOR PKWY. |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
RUSSELL J VARANO |
Correspondent |
FERTIL-A-CHRON, INC. |
350 MOTOR PKWY. |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
RUSSELL J VARANO |
Classification Product Code |
|
Date Received | 07/01/1985 |
Decision Date | 09/19/1985 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|