Cleared Traditional

CULTURE PLATES & TUBED MEDIA

K792481 · Laboratory Products, Inc. · Microbiology

Dec 1979

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K792481 is an FDA 510(k) clearance for the CULTURE PLATES & TUBED MEDIA, a Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (Class II — Special Controls, product code JTZ), submitted by Laboratory Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1979, 42 days after receiving the submission on November 19, 1979. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K792481 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 1979
Decision Date	December 31, 1979
Days to Decision	42 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