Cleared Traditional

ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN

K964670 · Roche Diagnostic Systems, Inc. · Toxicology
Feb 1997
Decision
75d
Days
Class 2
Risk

About This 510(k) Submission

K964670 is an FDA 510(k) clearance for the ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN, a Fluorescence Polarization Immunoassay, Tobramycin (Class II — Special Controls, product code LFW), submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on February 4, 1997, 75 days after receiving the submission on November 21, 1996. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K964670 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1996
Decision Date February 04, 1997
Days to Decision 75 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LFW — Fluorescence Polarization Immunoassay, Tobramycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3900

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