The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Toxoplasma Gondii Igg Elisa.
| Device ID | K871905 |
| 510k Number | K871905 |
| Device Name: | TOXOPLASMA GONDII IGG ELISA |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Contact | Labrec, Ph.d. |
| Correspondent | Labrec, Ph.d. ELECTRO-NUCLEONICS LABORATORIES, INC. 7101 RIVERWOOD DR. Columbia, MD 21046 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-15 |
| Decision Date | 1987-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516746960 | K871905 | 000 |
| 05391516743372 | K871905 | 000 |