Cleared Traditional

72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2

K850683 · Kent Laboratories, Inc. · Immunology
Nov 1985
Decision
279d
Days
Class 2
Risk

About This 510(k) Submission

K850683 is an FDA 510(k) clearance for the 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2, a Alpha-2-macroglobulin, Antigen, Antiserum, Control (Class II — Special Controls, product code DEB), submitted by Kent Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on November 27, 1985, 279 days after receiving the submission on February 21, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5620.

Submission Details

510(k) Number K850683 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1985
Decision Date November 27, 1985
Days to Decision 279 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DEB — Alpha-2-macroglobulin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5620

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