Cleared Traditional

VANCOMYCIN EIA ASSAY

K983280 · Diagnostic Reagents, Inc. · Toxicology
Nov 1998
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K983280 is an FDA 510(k) clearance for the VANCOMYCIN EIA ASSAY, a Radioimmunoassay, Vancomycin (Class II — Special Controls, product code LEH), submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 6, 1998, 49 days after receiving the submission on September 18, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3950.

Submission Details

510(k) Number K983280 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 1998
Decision Date November 06, 1998
Days to Decision 49 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LEH — Radioimmunoassay, Vancomycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3950

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