Cleared Traditional

RADIAL IMMUNODIFFUSION KIT-COMP. 3

K772073 · Gelman Instrument Co. · Immunology
Feb 1978
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K772073 is an FDA 510(k) clearance for the RADIAL IMMUNODIFFUSION KIT-COMP. 3, a Complement C4, Antigen, Antiserum, Control (Class II — Special Controls, product code DBI), submitted by Gelman Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on February 3, 1978, 92 days after receiving the submission on November 3, 1977. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K772073 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1977
Decision Date February 03, 1978
Days to Decision 92 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DBI — Complement C4, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240