Cleared Traditional

DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT

K963525 · Shield Diagnostics, Ltd. · Immunology

Nov 1996

Decision

64d

Days

Class 2

Risk

About This 510(k) Submission

K963525 is an FDA 510(k) clearance for the DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT, a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBL), submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on November 7, 1996, 64 days after receiving the submission on September 4, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K963525 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 1996
Decision Date	November 07, 1996
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5660