Cleared Traditional

HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER

K021081 · The Binding Site, Ltd. · Immunology
Jun 2002
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K021081 is an FDA 510(k) clearance for the HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER, a Igg (gamma Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DFZ), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on June 17, 2002, 75 days after receiving the submission on April 3, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K021081 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2002
Decision Date June 17, 2002
Days to Decision 75 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DFZ — Igg (gamma Chain Specific), Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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