Cleared Traditional

QUANTA LITE LKM-1 ELISA

K000535 · Inova Diagnostics, Inc. · Immunology

Jun 2000

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K000535 is an FDA 510(k) clearance for the QUANTA LITE LKM-1 ELISA, a Autoantibodies, Lkm-1 (liver/kidney Microsome, Type 1) (Class II — Special Controls, product code NBS), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on June 7, 2000, 111 days after receiving the submission on February 17, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K000535 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 17, 2000
Decision Date	June 07, 2000
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement