Cleared Traditional

K760063 - SPECIMEN COLLECTOR, ANAEROBIC (FDA 510(k) Clearance)

Aug 1976
Decision
48d
Days
Class 1
Risk

K760063 is an FDA 510(k) clearance for the SPECIMEN COLLECTOR, ANAEROBIC. This device is classified as a Transport Systems, Anaerobic (Class I - General Controls, product code JTX).

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 3, 1976, 48 days after receiving the submission on June 16, 1976.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K760063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1976
Decision Date August 03, 1976
Days to Decision 48 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JTX — Transport Systems, Anaerobic
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2900