The following data is part of a premarket notification filed by Princeton Biomedix with the FDA for Lifesign Mi Myoglobin.
| Device ID | K942052 |
| 510k Number | K942052 |
| Device Name: | LIFESIGN MI MYOGLOBIN |
| Classification | Myoglobin, Antigen, Antiserum, Control |
| Applicant | PRINCETON BIOMEDIX P.O. BOX 7139 Princeton, NJ 08543 -7139 |
| Contact | Jemo Kang,ph.d |
| Correspondent | Jemo Kang,ph.d PRINCETON BIOMEDIX P.O. BOX 7139 Princeton, NJ 08543 -7139 |
| Product Code | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-28 |
| Decision Date | 1995-02-07 |