Cleared Traditional

K843492 - NEOMYCIN BLOOD AGAR (FDA 510(k) Clearance)

Oct 1984
Decision
26d
Days
Class 1
Risk

K843492 is an FDA 510(k) clearance for the NEOMYCIN BLOOD AGAR. This device is classified as a Culture Media, Selective And Differential (Class I - General Controls, product code JSI).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 2, 1984, 26 days after receiving the submission on September 6, 1984.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K843492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date October 02, 1984
Days to Decision 26 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSI — Culture Media, Selective And Differential
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2360