Cleared Traditional

IAP PLATE TEST

K861336 · Scientific Sales Intl., Inc. · Immunology
Apr 1986
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K861336 is an FDA 510(k) clearance for the IAP PLATE TEST, a Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (Class I — General Controls, product code LKL), submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on April 25, 1986, 16 days after receiving the submission on April 9, 1986. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5420.

Submission Details

510(k) Number K861336 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1986
Decision Date April 25, 1986
Days to Decision 16 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code LKL — Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5420

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