Cleared Traditional

IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)

K012312 · Diagnostic Products Corp. · Toxicology
Aug 2001
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K012312 is an FDA 510(k) clearance for the IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS), a Radioimmunoassay, Tobramycin (Class II — Special Controls, product code KLB), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on August 20, 2001, 28 days after receiving the submission on July 23, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K012312 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 2001
Decision Date August 20, 2001
Days to Decision 28 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code KLB — Radioimmunoassay, Tobramycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3900

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