Cleared Traditional

IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)

K012301 · Diagnostic Products Corp. · Toxicology
Sep 2001
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K012301 is an FDA 510(k) clearance for the IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS), a Enzyme Immunoassay, Digoxin (Class II — Special Controls, product code KXT), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on September 19, 2001, 61 days after receiving the submission on July 20, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number K012301 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2001
Decision Date September 19, 2001
Days to Decision 61 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KXT — Enzyme Immunoassay, Digoxin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3320

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