Cleared Traditional

BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT

K030238 · The Binding Site, Ltd. · Immunology

Mar 2003

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K030238 is an FDA 510(k) clearance for the BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT, a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBM), submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on March 24, 2003, 60 days after receiving the submission on January 23, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5090.

Submission Details

510(k) Number	K030238 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 2003
Decision Date	March 24, 2003
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5090