Cleared Traditional

PLEASCENT OR FORMA-SCENT

K802506 · Meridian Diagnostics, Inc. · Pathology
Nov 1980
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K802506 is an FDA 510(k) clearance for the PLEASCENT OR FORMA-SCENT, a Formaldehyde (formalin, Formol) (Class I — General Controls, product code IGG), submitted by Meridian Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on November 12, 1980, 28 days after receiving the submission on October 15, 1980. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K802506 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1980
Decision Date November 12, 1980
Days to Decision 28 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IGG — Formaldehyde (formalin, Formol)
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010