Cleared Traditional

VISI-SPOT

K932752 · J.S. Medical Assoc. · Microbiology
Nov 1993
Decision
170d
Days
Class 1
Risk

About This 510(k) Submission

K932752 is an FDA 510(k) clearance for the VISI-SPOT, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on November 5, 1993, 170 days after receiving the submission on May 19, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K932752 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1993
Decision Date November 05, 1993
Days to Decision 170 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