Cleared Traditional

MODIFIED PARACON(TM) CONCENTRATION KIT

K881649 · Para Scientific Co. · Microbiology
Apr 1988
Decision
6d
Days
Class 1
Risk

About This 510(k) Submission

K881649 is an FDA 510(k) clearance for the MODIFIED PARACON(TM) CONCENTRATION KIT, 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 April 21, 1988, 6 days after receiving the submission on April 15, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K881649 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1988
Decision Date April 21, 1988
Days to Decision 6 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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