Cleared Traditional

K863527 - CARY-BLAIR TRANSPORT MEDIUM (FDA 510(k) Clearance)

Sep 1986
Decision
9d
Days
Class 1
Risk

K863527 is an FDA 510(k) clearance for the CARY-BLAIR TRANSPORT MEDIUM. This device is classified as a Culture Media, Non-propagating Transport (Class I - General Controls, product code JSM).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 19, 1986, 9 days after receiving the submission on September 10, 1986.

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

Submission Details

510(k) Number K863527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1986
Decision Date September 19, 1986
Days to Decision 9 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSM — Culture Media, Non-propagating Transport
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2390