The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Parathyroid Hormone Test System/nichols Advantage Quick-intraoperative Bio-intact Pth (1-84).
| Device ID | K022472 |
| 510k Number | K022472 |
| Device Name: | PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-26 |
| Decision Date | 2002-10-09 |
| Summary: | summary |