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 |