The following data is part of a premarket notification filed by Princeton Biomedix with the FDA for Biosign(tm) Mono-infect Mono Hetero Antibody Test.
| Device ID | K925183 |
| 510k Number | K925183 |
| Device Name: | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST |
| Classification | System, Test, Infectious Mononucleosis |
| 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 | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-14 |
| Decision Date | 1993-02-23 |