The following data is part of a premarket notification filed by Trinity Biotech, Inc. with the FDA for Herpes Group Igg.
| Device ID | K033059 |
| 510k Number | K033059 |
| Device Name: | HERPES GROUP IGG |
| Classification | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Applicant | TRINITY BIOTECH, INC. PO BOX 1059 Jamestown, NY 14702 |
| Contact | Bonnie Dejoy |
| Correspondent | Bonnie Dejoy TRINITY BIOTECH, INC. PO BOX 1059 Jamestown, NY 14702 |
| Product Code | LGC |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2003-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746496 | K033059 | 000 |