Cleared Traditional

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR

K852317 · Roche Diagnostic Systems, Inc. · Toxicology
Jun 1985
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K852317 is an FDA 510(k) clearance for the COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR, a Radioimmunoassay, Amikacin (Class II — Special Controls, product code KLQ), submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on June 25, 1985, 25 days after receiving the submission on May 31, 1985. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3035.

Submission Details

510(k) Number K852317 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1985
Decision Date June 25, 1985
Days to Decision 25 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code KLQ — Radioimmunoassay, Amikacin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3035