Cleared Traditional

WIELISA ANTI-GBM TEST SYSTEM

K974169 · Wieslab AB · Immunology

Feb 1998

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K974169 is an FDA 510(k) clearance for the WIELISA ANTI-GBM TEST SYSTEM, a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBL), submitted by Wieslab AB (Frederick, US). The FDA issued a Cleared decision on February 17, 1998, 104 days after receiving the submission on November 5, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K974169 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 1997
Decision Date	February 17, 1998
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

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