Cleared Traditional

K001900 - ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
(FDA 510(k) Clearance)

K001900 · Helix Diagnostics, Inc. · Immunology

Sep 2000

Decision

81d

Days

Class 2

Risk

K001900 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST, a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II — Special Controls, product code LRM), submitted by Helix Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on September 11, 2000, 81 days after receiving the submission on June 22, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K001900 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 2000
Decision Date	September 11, 2000
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement