Cleared Traditional

HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT

K951967 · Kent Laboratories, Inc. · Immunology

May 1995

Decision

33d

Days

Class 2

Risk

About This 510(k) Submission

K951967 is an FDA 510(k) clearance for the HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT, a Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (Class II — Special Controls, product code DBA), 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 866.5250.

Submission Details

510(k) Number	K951967 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	Summary PDF

Device Classification

Product Code	DBA — Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5250