Cleared Traditional

ANTI-GBM ANTIBODIES QUANTITATIVE KIT

K904181 · Biochemical Diagnostic, Inc. · Immunology

Sep 1991

Decision

364d

Days

Class 2

Risk

About This 510(k) Submission

K904181 is an FDA 510(k) clearance for the ANTI-GBM ANTIBODIES QUANTITATIVE KIT, a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBL), submitted by Biochemical Diagnostic, Inc. (Sweden, SE). The FDA issued a Cleared decision on September 10, 1991, 364 days after receiving the submission on September 11, 1990. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K904181 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 1990
Decision Date	September 10, 1991
Days to Decision	364 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—

Device Classification

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