The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Toxoplasma Igg Microassay.
| Device ID | K863813 |
| 510k Number | K863813 |
| Device Name: | TOXOPLASMA IGG MICROASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | Lin, Ph.d. |
| Correspondent | Lin, Ph.d. DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-30 |
| Decision Date | 1986-11-28 |