Cleared Traditional

K871094 - BRILLIANT GREEN AGAR (FDA 510(k) Clearance)

Apr 1987
Decision
16d
Days
Class 1
Risk

K871094 is an FDA 510(k) clearance for the BRILLIANT GREEN AGAR. This device is classified as a Culture Media, Selective And Differential (Class I - General Controls, product code JSI).

Submitted by bioMerieux, Inc. (Addison, US). The FDA issued a Cleared decision on April 3, 1987, 16 days after receiving the submission on March 18, 1987.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K871094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1987
Decision Date April 03, 1987
Days to Decision 16 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSI — Culture Media, Selective And Differential
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2360