Cleared Traditional

K781304 - TRANSPORT MEDIA (FDA 510(k) Clearance)

Aug 1978
Decision
18d
Days
Class 1
Risk

K781304 is an FDA 510(k) clearance for the TRANSPORT MEDIA. This device is classified as a Culture Media, Propagating Transport (Class I - General Controls, product code JSN).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 14, 1978, 18 days after receiving the submission on July 27, 1978.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K781304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1978
Decision Date August 14, 1978
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSN — Culture Media, Propagating Transport
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2390