Cleared Traditional

K871786 - GBNA MEDIUM (FDA 510(k) Clearance)

May 1987
Decision
15d
Days
Class 1
Risk

K871786 is an FDA 510(k) clearance for the GBNA MEDIUM. This device is classified as a Culture Media, Selective And Non-differential (Class I - General Controls, product code JSJ).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 21, 1987, 15 days after receiving the submission on May 6, 1987.

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

Submission Details

510(k) Number K871786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1987
Decision Date May 21, 1987
Days to Decision 15 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSJ — Culture Media, Selective And Non-differential
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2360