Cleared Traditional

PARA-PRO FC50

K053257 · Alpha-Tec Systems, Inc. · Microbiology
May 2006
Decision
171d
Days
Class 1
Risk

About This 510(k) Submission

K053257 is an FDA 510(k) clearance for the PARA-PRO FC50, a Device, Parasite Concentration (Class I — General Controls, product code LKS), submitted by Alpha-Tec Systems, Inc. (Vancouver, US). The FDA issued a Cleared decision on May 12, 2006, 171 days after receiving the submission on November 22, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K053257 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2005
Decision Date May 12, 2006
Days to Decision 171 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LKS — Device, Parasite Concentration
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900