Cleared Traditional

PARAKIT

K941110 · Hardy Diagnostics · Microbiology
May 1994
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K941110 is an FDA 510(k) clearance for the PARAKIT, a Device, Parasite Concentration (Class I — General Controls, product code LKS), submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on May 17, 1994, 71 days after receiving the submission on March 7, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K941110 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1994
Decision Date May 17, 1994
Days to Decision 71 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