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 |