The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Chemiluminescence Thyroglobulin, Model 60-4240.
| Device ID | K994140 |
| 510k Number | K994140 |
| Device Name: | NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240 |
| Classification | System, Test, Thyroglobulin |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Contact | Jimmy Wong |
| Correspondent | Jimmy Wong NICHOLS INSTITUTE DIAGNOSTICS 33051 CALLE AVIADOR San Juan Capistrano, CA 92675 |
| Product Code | MSW |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-08 |
| Decision Date | 2000-05-09 |
| Summary: | summary |