Cleared Traditional

NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE

K880947 · Lakewood Biochemical Co., Inc. · Microbiology
Apr 1988
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K880947 is an FDA 510(k) clearance for the NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE, a Culture Media, Non-selective And Non-differential (Class I — General Controls, product code JSG), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on April 1, 1988, 25 days after receiving the submission on March 7, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2300.

Submission Details

510(k) Number K880947 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1988
Decision Date April 01, 1988
Days to Decision 25 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JSG — Culture Media, Non-selective And Non-differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2300

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