Cleared Traditional

MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181

K882351 · Lakewood Biochemical Co., Inc. · Microbiology

Jun 1988

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K882351 is an FDA 510(k) clearance for the MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181, a Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (Class II — Special Controls, product code JTZ), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on June 28, 1988, 21 days after receiving the submission on June 7, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K882351 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 1988
Decision Date	June 28, 1988
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—

Device Classification

Product Code	JTZ — Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1700