Cleared Traditional

CONSED FECAL CONCENTRATION SYSTEM

K884755 · Donald L. Price, Ph.D. · Pathology
Jan 1989
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K884755 is an FDA 510(k) clearance for the CONSED FECAL CONCENTRATION SYSTEM, a Formalin, Neutral Buffered (Class I — General Controls, product code IFP), submitted by Donald L. Price, Ph.D. (Bradenton, US). The FDA issued a Cleared decision on January 10, 1989, 57 days after receiving the submission on November 14, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K884755 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1988
Decision Date January 10, 1989
Days to Decision 57 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IFP — Formalin, Neutral Buffered
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010