Cleared Traditional

REMEL SPECTRA MRSA

K092407 · Remel, Inc. · Microbiology

Oct 2010

Decision

428d

Days

Class 2

Risk

About This 510(k) Submission

K092407 is an FDA 510(k) clearance for the REMEL SPECTRA MRSA, a Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (Class II — Special Controls, product code JSO), submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on October 8, 2010, 428 days after receiving the submission on August 6, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1700.

Submission Details

510(k) Number	K092407 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2009
Decision Date	October 08, 2010
Days to Decision	428 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

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