Cleared Traditional

DMAC INDOLE REAGENT

K901390 · Analytical Products, Inc. · Microbiology
Apr 1990
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K901390 is an FDA 510(k) clearance for the DMAC INDOLE REAGENT, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on April 16, 1990, 21 days after receiving the submission on March 26, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K901390 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1990
Decision Date April 16, 1990
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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