Cleared Traditional

K874344 - QUAD PLATE (4 DIFFERENT MEDIA)
(FDA 510(k) Clearance)

K874344 · Lakewood Biochemical Co., Inc. · Microbiology
Nov 1987
Decision
17d
Days
Class 1
Risk

K874344 is an FDA 510(k) clearance for the QUAD PLATE (4 DIFFERENT MEDIA). This device is classified as a Culture Media, Selective And Differential (Class I — General Controls, product code JSI).

Submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on November 6, 1987, 17 days after receiving the submission on October 20, 1987.

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

Submission Details

510(k) Number K874344 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1987
Decision Date November 06, 1987
Days to Decision 17 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