Cleared Traditional

K880254 - SM ANTIBODY TEST KIT
(FDA 510(k) Clearance)

K880254 · Lipogen, Inc. · Immunology

Apr 1988

Decision

77d

Days

Class 2

Risk

K880254 is an FDA 510(k) clearance for the SM ANTIBODY TEST KIT. This device is classified as a Anti-sm Antibody, Antigen And Control (Class II — Special Controls, product code LKP).

Submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on April 6, 1988, 77 days after receiving the submission on January 20, 1988.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K880254 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 20, 1988
Decision Date	April 06, 1988
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—