Cleared Traditional

PARA-PAK SPINCON

K980077 · Meridian Diagnostics, Inc. · Microbiology
Apr 1998
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K980077 is an FDA 510(k) clearance for the PARA-PAK SPINCON, a Device, Parasite Concentration (Class I — General Controls, product code LKS), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 2, 1998, 84 days after receiving the submission on January 8, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K980077 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 1998
Decision Date April 02, 1998
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

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