Cleared Traditional

SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389

K024162 · Helena Laboratories · Immunology
Feb 2003
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K024162 is an FDA 510(k) clearance for the SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389, a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II — Special Controls, product code CFF), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on February 19, 2003, 64 days after receiving the submission on December 17, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K024162 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2002
Decision Date February 19, 2003
Days to Decision 64 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

Similar Devices — CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)

All 28
HYDRASHIFT 2/4 isatuximab
K203184 · Sebia · Nov 2021
CAPI 3 Immunotyping, Capillarys 3 Tera
K192095 · Sebia · Nov 2019
HYDRASHIFT 2/4 daratumumab
K190851 · Sebia · May 2019
HYDRASHIFT 2/4 daratumumab, daratumumab Control
K172195 · Sebia · Jan 2018
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL
K161928 · Sebia · Dec 2016
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING
K143483 · Sebia · Jan 2015