Cleared Traditional

IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)

K012311 · Diagnostic Products Corp. · Chemistry
Aug 2001
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K012311 is an FDA 510(k) clearance for the IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS), a Enzyme Immunoassay, Gentamicin (Class II — Special Controls, product code LCD), 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 Chemistry review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K012311 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 Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCD — Enzyme Immunoassay, Gentamicin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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