The following data is part of a premarket notification filed by Cytotech, Inc. with the FDA for Cytotech Toxoplasma Igg Enzyme Immunoassay.
| Device ID | K863363 |
| 510k Number | K863363 |
| Device Name: | CYTOTECH TOXOPLASMA IGG ENZYME IMMUNOASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | CYTOTECH, INC. 11035 ROSELLE STREET, SUITE A San Diego, CA 92121 |
| Contact | Kiehl, Phd |
| Correspondent | Kiehl, Phd CYTOTECH, INC. 11035 ROSELLE STREET, SUITE A San Diego, CA 92121 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-02 |
| Decision Date | 1986-11-13 |