Cleared Traditional

EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS

K962519 · Behring Diagnostics, Inc. · Toxicology
Sep 1996
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K962519 is an FDA 510(k) clearance for the EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS, a Enzyme Immunoassay, Gentamicin (Class II — Special Controls, product code LCD), submitted by Behring Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on September 4, 1996, 69 days after receiving the submission on June 27, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K962519 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 1996
Decision Date September 04, 1996
Days to Decision 69 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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