Cleared Special

IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6

K013566 · Diagnostic Products Corp. · Chemistry
Nov 2001
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K013566 is an FDA 510(k) clearance for the IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on November 20, 2001, 25 days after receiving the submission on October 26, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K013566 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2001
Decision Date November 20, 2001
Days to Decision 25 days
Submission Type Special
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