The following data is part of a premarket notification filed by Princeton Biomedix with the FDA for Biosign(tm_ Rubella - Rubella Antibody Test.
| Device ID | K925355 |
| 510k Number | K925355 |
| Device Name: | BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| 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 | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-22 |
| Decision Date | 1994-07-12 |