The following data is part of a premarket notification filed by Trinity Biotech Usa with the FDA for Macra Lp(a) Enzyme Immunoassay Kit.
| Device ID | K992665 |
| 510k Number | K992665 |
| Device Name: | MACRA LP(A) ENZYME IMMUNOASSAY KIT |
| Classification | Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Applicant | TRINITY BIOTECH USA P.O. BOX 1059 Jamestown, NY 14702 -1059 |
| Contact | Wayne A Kvetkosky |
| Correspondent | Wayne A Kvetkosky TRINITY BIOTECH USA P.O. BOX 1059 Jamestown, NY 14702 -1059 |
| Product Code | DFC |
| CFR Regulation Number | 866.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-09 |
| Decision Date | 1999-11-26 |