Cleared Traditional

K760588 - IMPROVED THAYER MARTIN MEDIUM (FDA 510(k) Clearance)

Oct 1976
Decision
34d
Days
Class 2
Risk

K760588 is an FDA 510(k) clearance for the IMPROVED THAYER MARTIN MEDIUM. This device is classified as a Culture Media, For Isolation Of Pathogenic Neisseria (Class II - Special Controls, product code JTY).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 7, 1976, 34 days after receiving the submission on September 3, 1976.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2410.

Submission Details

510(k) Number K760588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1976
Decision Date October 07, 1976
Days to Decision 34 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JTY — Culture Media, For Isolation Of Pathogenic Neisseria
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.2410