The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Advantage Bio-intact Pth (1-84) Assay, Model 62-7040.
| Device ID | K033302 |
| 510k Number | K033302 |
| Device Name: | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO San Clemente, CA 92673 |
| Contact | Jimmy Wong |
| Correspondent | Jimmy Wong NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO San Clemente, CA 92673 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-14 |
| Decision Date | 2004-01-26 |
| Summary: | summary |