Cleared Traditional

K832954 - V AGAR (FDA 510(k) Clearance)

Sep 1983
Decision
29d
Days
Class 1
Risk

K832954 is an FDA 510(k) clearance for the V 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 September 29, 1983, 29 days after receiving the submission on August 31, 1983.

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

Submission Details

510(k) Number K832954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1983
Decision Date September 29, 1983
Days to Decision 29 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