Cleared Traditional

SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST

K061496 · Sa Scientific , Ltd. · Microbiology

Jun 2007

Decision

393d

Days

Class 2

Risk

About This 510(k) Submission

K061496 is an FDA 510(k) clearance for the SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST, a Legionella, Spp., Elisa (Class II — Special Controls, product code MJH), submitted by Sa Scientific , Ltd. (San Antonio, US). The FDA issued a Cleared decision on June 28, 2007, 393 days after receiving the submission on May 31, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3300.

Submission Details

510(k) Number	K061496 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2006
Decision Date	June 28, 2007
Days to Decision	393 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF