Cleared Traditional

72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL

K850682 · Kent Laboratories, Inc. · Immunology
Nov 1985
Decision
277d
Days
Class 2
Risk

About This 510(k) Submission

K850682 is an FDA 510(k) clearance for the 72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL, a Ceruloplasmin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDB), submitted by Kent Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on November 25, 1985, 277 days after receiving the submission on February 21, 1985. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5210.

Submission Details

510(k) Number K850682 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1985
Decision Date November 25, 1985
Days to Decision 277 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DDB — Ceruloplasmin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5210

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