The following data is part of a premarket notification filed by Joel R.l. Ehren Kranz with the FDA for Ovudate.
| Device ID | K844043 |
| 510k Number | K844043 |
| Device Name: | OVUDATE |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | JOEL R.L. EHREN KRANZ 60 FRANKLIN ST. Morristown, NJ 07960 |
| Product Code | LHD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-17 |
| Decision Date | 1985-02-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OVUDATE 73571700 1401048 Dead/Cancelled |
FRANKLIN DIAGNOSTICS, INC. 1985-12-05 |