Cleared Traditional

IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT

K971464 · Euro-Diagnostica AB · Immunology

Oct 1997

Decision

190d

Days

Class 2

Risk

About This 510(k) Submission

K971464 is an FDA 510(k) clearance for the IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT, a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBL), submitted by Euro-Diagnostica AB (Ringoes, US). The FDA issued a Cleared decision on October 29, 1997, 190 days after receiving the submission on April 22, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K971464 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 1997
Decision Date	October 29, 1997
Days to Decision	190 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