Cleared Traditional

POS COMBO PANEL

K844086 · American Micro Scan · Microbiology
Nov 1984
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K844086 is an FDA 510(k) clearance for the POS COMBO PANEL, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by American Micro Scan (Sacramento, US). The FDA issued a Cleared decision on November 13, 1984, 22 days after receiving the submission on October 22, 1984. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K844086 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1984
Decision Date November 13, 1984
Days to Decision 22 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