Cleared Traditional

DIASTAT ANTI-JO-1 KIT

K912292 · Shield Diagnostics, Ltd. · Immunology

Jul 1991

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K912292 is an FDA 510(k) clearance for the DIASTAT ANTI-JO-1 KIT, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on July 30, 1991, 68 days after receiving the submission on May 23, 1991. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K912292 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 1991
Decision Date	July 30, 1991
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

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