Cleared Traditional

HUMAN C-5 RADIAL IMMUNODIFFUSION KIT

K950102 · Kent Laboratories, Inc. · Immunology

Apr 1995

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K950102 is an FDA 510(k) clearance for the HUMAN C-5 RADIAL IMMUNODIFFUSION KIT, a Complement C5, Antigen, Antiserum, Control (Class II — Special Controls, product code DAY), submitted by Kent Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on April 10, 1995, 89 days after receiving the submission on January 11, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number	K950102 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 1995
Decision Date	April 10, 1995
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement