The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Ovusign - One-step Home Ovulation Predictor Test.
| Device ID | K963693 |
| 510k Number | K963693 |
| Device Name: | OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 -7139 |
| Contact | Jemo Kang, Ph.d. |
| Correspondent | Jemo Kang, Ph.d. PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 -7139 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1996-11-29 |