Cleared Traditional

VARELISA M2 ANTIBODIES

K945607 · Elias U.S.A., Inc. · Immunology

Jan 1995

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K945607 is an FDA 510(k) clearance for the VARELISA M2 ANTIBODIES, a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBM), submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on January 24, 1995, 70 days after receiving the submission on November 15, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5090.

Submission Details

510(k) Number	K945607 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 15, 1994
Decision Date	January 24, 1995
Days to Decision	70 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