Cleared Traditional

GRAM SWAB

K970834 · Remel, Inc. · Microbiology
Apr 1997
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K970834 is an FDA 510(k) clearance for the GRAM SWAB, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on April 17, 1997, 41 days after receiving the submission on March 7, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K970834 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1997
Decision Date April 17, 1997
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JTO — Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660