Cleared Traditional

ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS)

K021257 · Diagnostic Products Corp. · Immunology
Jun 2002
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K021257 is an FDA 510(k) clearance for the ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS), a Antinuclear Antibody, Antigen, Control (Class II — Special Controls, product code LKJ), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on June 3, 2002, 45 days after receiving the submission on April 19, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K021257 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2002
Decision Date June 03, 2002
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LKJ — Antinuclear Antibody, Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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