Cleared Traditional

PARACON II/FECAL CONCENTRATOR II

K021420 · Para Scientific Co. · Microbiology
Jun 2002
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K021420 is an FDA 510(k) clearance for the PARACON II/FECAL CONCENTRATOR II, a Device, Parasite Concentration (Class I — General Controls, product code LKS), submitted by Para Scientific Co. (Lake Oswego, US). The FDA issued a Cleared decision on June 4, 2002, 32 days after receiving the submission on May 3, 2002. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K021420 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2002
Decision Date June 04, 2002
Days to Decision 32 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