Cleared Traditional

PARA-PAK PLUS

K931770 · Meridian Diagnostics, Inc. · Microbiology
Jun 1993
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K931770 is an FDA 510(k) clearance for the PARA-PAK PLUS, a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 15, 1993, 67 days after receiving the submission on April 9, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K931770 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1993
Decision Date June 15, 1993
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIO — Device, Specimen Collection
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2900

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