Cleared Traditional

KALLESTAD SSA/SSB ENA TEST REAGENTS

K862710 · Kallestad Laboratories, Inc. · Immunology
Jul 1986
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K862710 is an FDA 510(k) clearance for the KALLESTAD SSA/SSB ENA TEST REAGENTS, a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on July 29, 1986, 13 days after receiving the submission on July 16, 1986. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K862710 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1986
Decision Date July 29, 1986
Days to Decision 13 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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