The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Toxonostika Igm Microelisa System.
| Device ID | K862196 |
| 510k Number | K862196 |
| Device Name: | TOXONOSTIKA IGM MICROELISA SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | ORGANON TEKNIKA CORP. 5516 NICHOLSON LN. Kensington, TX 20895 |
| Contact | Sheldon Mazursky |
| Correspondent | Sheldon Mazursky ORGANON TEKNIKA CORP. 5516 NICHOLSON LN. Kensington, TX 20895 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-09 |
| Decision Date | 1986-09-11 |