The following data is part of a premarket notification filed by Lmd Laboratories with the FDA for Trend(r) Emerge(tm) Toxoplasma Igg Elisa.
| Device ID | K883720 |
| 510k Number | K883720 |
| Device Name: | TREND(R) EMERGE(TM) TOXOPLASMA IGG ELISA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | LMD LABORATORIES 4626 SANTA FE ST. San Diego, CA 92109 |
| Contact | Dave Lambillotte |
| Correspondent | Dave Lambillotte LMD LABORATORIES 4626 SANTA FE ST. San Diego, CA 92109 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-31 |
| Decision Date | 1989-01-24 |