Cleared Traditional

OPTIMATE IGA TEST

K841815 · Miles Laboratories, Inc. · Immunology
Jun 1984
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K841815 is an FDA 510(k) clearance for the OPTIMATE IGA TEST, a Iga, Fitc, Antigen, Antiserum, Control (Class II — Special Controls, product code CZN), submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1984, 31 days after receiving the submission on May 1, 1984. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K841815 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1984
Decision Date June 01, 1984
Days to Decision 31 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code CZN — Iga, Fitc, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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