Cleared Traditional

PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF

K964144 · Para Scientific Co. · Microbiology
Nov 1996
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K964144 is an FDA 510(k) clearance for the PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AND PARACON PLUS MF - PCP-MF, a Device, Specimen Collection (Class I — General Controls, product code LIO), submitted by Para Scientific Co. (Lake Oswego, US). The FDA issued a Cleared decision on November 27, 1996, 41 days after receiving the submission on October 17, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K964144 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 1996
Decision Date November 27, 1996
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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

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