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 |