Cleared Traditional

ANA APPLELISA

K834241 · Apple Diagnostic Products · Immunology

Apr 1984

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K834241 is an FDA 510(k) clearance for the ANA APPLELISA, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Apple Diagnostic Products (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984, 120 days after receiving the submission on December 6, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K834241 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 1983
Decision Date	April 04, 1984
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—

Device Classification

Product Code	DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5100