Cleared Traditional

NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022

K040813 · Nichols Institute Diagnostics · Chemistry
Jun 2004
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K040813 is an FDA 510(k) clearance for the NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Nichols Institute Diagnostics (San Clemente, US). The FDA issued a Cleared decision on June 8, 2004, 70 days after receiving the submission on March 30, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K040813 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2004
Decision Date June 08, 2004
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEW — Radioimmunoassay, Parathyroid Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1545

Similar Devices — CEW Radioimmunoassay, Parathyroid Hormone

All 85
Elecsys PTH , Elecsys PTH STAT
K231927 · Roche Diagnostics · Mar 2024
Access Intact PTH
K232791 · Beckman Coulter, Inc. · Mar 2024
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
K221197 · Ortho-Clinical Diagnostics · Sep 2023
Lumipulse G whole PTH
K190702 · Fujirebio Diagnostics,Inc. · Aug 2019
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
K163658 · Siemens Healthcare Diagnostics, Inc. · May 2017
IDS-iSYS Intact PTHN
K161158 · Immunodiagnostic Systems , Ltd. · Jan 2017