Cleared Traditional

HAEMOPHILUS TEST MEDIUM AGAR (HTM)

K962744 · Prepared Media Laboratory, Inc. · Microbiology

Oct 1996

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K962744 is an FDA 510(k) clearance for the HAEMOPHILUS TEST MEDIUM AGAR (HTM), a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by Prepared Media Laboratory, Inc. (Portland, US). The FDA issued a Cleared decision on October 15, 1996, 92 days after receiving the submission on July 15, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K962744 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 1996
Decision Date	October 15, 1996
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

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