The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Elisa Toxo Igm.
| Device ID | K914852 |
| 510k Number | K914852 |
| Device Name: | ELISA TOXO IGM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | Martin King |
| Correspondent | Martin King SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-28 |
| Decision Date | 1992-01-23 |