Cleared Traditional

HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT

K951966 · Kent Laboratories, Inc. · Immunology
Jun 1995
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K951966 is an FDA 510(k) clearance for the HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT, a Prealbumin, Antigen, Antiserum, Control (Class I — General Controls, product code JZJ), submitted by Kent Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on June 1, 1995, 35 days after receiving the submission on April 27, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5060.

Submission Details

510(k) Number K951966 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1995
Decision Date June 01, 1995
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JZJ — Prealbumin, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5060

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