The following data is part of a premarket notification filed by Nichols Institute with the FDA for Tsh - Third Generation Low Controls.
| Device ID | K924675 |
| 510k Number | K924675 |
| Device Name: | TSH - THIRD GENERATION LOW CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-16 |
| Decision Date | 1992-11-18 |