Cleared Traditional

HUMAN C1Q RADIAL IMMUNODIFFUSION KIT

K951968 · Kent Laboratories, Inc. · Immunology
May 1995
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K951968 is an FDA 510(k) clearance for the HUMAN C1Q RADIAL IMMUNODIFFUSION KIT, a Complement C1q, Antigen, Antiserum, Control (Class II — Special Controls, product code DAK), submitted by Kent Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on May 30, 1995, 33 days after receiving the submission on April 27, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K951968 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1995
Decision Date May 30, 1995
Days to Decision 33 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DAK — Complement C1q, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

Similar Devices — DAK Complement C1q, Antigen, Antiserum, Control

All 27
BINDAZYME CLQ CIC EIA KIT
K031563 · The Binding Site, Ltd. · Sep 2003
IBL C1Q-CIC CIA TEST
K032254 · Ibl GmbH · Aug 2003
CIC-C1Q EIA
K012576 · American Laboratory Products Co., Ltd. · Jan 2002
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES
K973203 · Sangstat Medical Corp. · Sep 1998
IMMUSTRIP HAMA IGG
K972873 · Immunomedics, Inc. · Mar 1998
C1 RID KIT
K914388 · The Binding Site, Ltd. · Oct 1991