Cleared Traditional

WESBLOT RNP-SM TEST

K881379 · American Bionetics, Inc. · Immunology

May 1988

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K881379 is an FDA 510(k) clearance for the WESBLOT RNP-SM TEST, a Anti-sm Antibody, Antigen And Control (Class II — Special Controls, product code LKP), submitted by American Bionetics, Inc. (Hayward, US). The FDA issued a Cleared decision on May 16, 1988, 45 days after receiving the submission on April 1, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K881379 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 1988
Decision Date	May 16, 1988
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—