Cleared Traditional

ACS GENTAMICIN

K953020 · Ciba Corning Diagnostics Corp. · Toxicology
Aug 1995
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K953020 is an FDA 510(k) clearance for the ACS GENTAMICIN, a Enzyme Immunoassay, Gentamicin (Class II — Special Controls, product code LCD), submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on August 2, 1995, 34 days after receiving the submission on June 29, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K953020 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1995
Decision Date August 02, 1995
Days to Decision 34 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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