The following data is part of a premarket notification filed by Nichols Institute with the FDA for Thyroid Peroxidase Auto Antibodies(tpo) Immun Kit.
| Device ID | K931311 |
| 510k Number | K931311 |
| Device Name: | THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | NICHOLS INSTITUTE 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 |
| Contact | Salvadore Palomares |
| Correspondent | Salvadore Palomares NICHOLS INSTITUTE 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-15 |
| Decision Date | 1993-05-14 |