Cleared Traditional

K864014 - LOMBARD DOWELL AGAR BASE (FDA 510(k) Clearance)

Oct 1986
Decision
14d
Days
Class 1
Risk

K864014 is an FDA 510(k) clearance for the LOMBARD DOWELL AGAR BASE. This device is classified as a Culture Media, Enriched (Class I - General Controls, product code KZI).

Submitted by Gibco Laboratories Life Technologies, Inc. (Madison, US). The FDA issued a Cleared decision on October 29, 1986, 14 days after receiving the submission on October 15, 1986.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2330.

Submission Details

510(k) Number K864014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1986
Decision Date October 29, 1986
Days to Decision 14 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code KZI — Culture Media, Enriched
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2330