The following data is part of a premarket notification filed by Princeton Biomedix with the FDA for Lifesign Hcg - One Step Home Pregnancy Test.
| Device ID | K926308 |
| 510k Number | K926308 |
| Device Name: | LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| 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 | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-15 |
| Decision Date | 1993-01-26 |