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) Immunoassay.
| Device ID | K033727 |
| 510k Number | K033727 |
| Device Name: | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO San Clemente, CA 92673 |
| Contact | Robert L Schmidt |
| Correspondent | Robert L Schmidt NICHOLS INSTITUTE DIAGNOSTICS 1311 CALLE BATIDO San Clemente, CA 92673 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-28 |
| Decision Date | 2004-04-22 |
| Summary: | summary |