Cleared Traditional

PCTE MICROPOROUS MEMBRANE FILTER

K870196 · Poretics Corp. · Pathology
May 1987
Decision
112d
Days
Class 1
Risk

About This 510(k) Submission

K870196 is an FDA 510(k) clearance for the PCTE MICROPOROUS MEMBRANE FILTER, a Filters, Cell Collection, Tissue Processing (Class I — General Controls, product code KET), submitted by Poretics Corp. (Livermore, US). The FDA issued a Cleared decision on May 12, 1987, 112 days after receiving the submission on January 20, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number K870196 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 1987
Decision Date May 12, 1987
Days to Decision 112 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KET — Filters, Cell Collection, Tissue Processing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3010