The following data is part of a premarket notification filed by Princeton Biomedix with the FDA for Ovusign Lh/conception Plus/ovudate Lh One-step.
| Device ID | K930185 |
| 510k Number | K930185 |
| Device Name: | OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | PRINCETON BIOMEDIX P.O. BOX 7139 Princeton, NJ 08543 -7139 |
| Contact | Jemo Kang |
| Correspondent | Jemo Kang PRINCETON BIOMEDIX 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 | 1993-01-14 |
| Decision Date | 1993-03-04 |