Cleared Traditional

K951206 - VARELISA PARIETAL CELL ANTIBODIES
(FDA 510(k) Clearance)

K951206 · Elias U.S.A., Inc. · Immunology

Apr 1995

Decision

31d

Days

Class 2

Risk

K951206 is an FDA 510(k) clearance for the VARELISA PARIETAL CELL ANTIBODIES, a Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control (Class II — Special Controls, product code MLE), submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on April 17, 1995, 31 days after receiving the submission on March 17, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5110.

Submission Details

510(k) Number	K951206 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 1995
Decision Date	April 17, 1995
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	MLE — Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5110