Cleared Traditional

PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN

K853497 · Surgipath Medical Industries, Inc. · Pathology
Aug 1985
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K853497 is an FDA 510(k) clearance for the PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN, a Formalin, Neutral Buffered (Class I — General Controls, product code IFP), submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on August 28, 1985, 8 days after receiving the submission on August 20, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K853497 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1985
Decision Date August 28, 1985
Days to Decision 8 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