Cleared Traditional

HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)

K090920 · The Binding Site, Ltd. · Immunology
Dec 2009
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K090920 is an FDA 510(k) clearance for the HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P), a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on December 30, 2009, 273 days after receiving the submission on April 1, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K090920 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2009
Decision Date December 30, 2009
Days to Decision 273 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CFN — Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

Similar Devices — CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 60
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
K233663 · Siemens Healthcare Diagnostics Products GmbH · Dec 2023
Immunoglobulin G (IgG)
K221114 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · Aug 2023
Human IgA liquid reagent kit for Use on SPAPlus
K192116 · The Binding Site Group , Ltd. · Sep 2019
Optilite IgA Kit
K191985 · The Binding Site Group , Ltd. · Aug 2019
Optilite IgM Kit
K191635 · The Binding Site Group , Ltd. · Jul 2019
Human IgM Kit for use on SPAPlus
K191465 · The Binding Site Group , Ltd. · Jun 2019