Cleared Traditional

10% NEUTRAL BUFFERED FORMALIN CONCENT

K812940 · Surgipath · Pathology
Dec 1981
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K812940 is an FDA 510(k) clearance for the 10% NEUTRAL BUFFERED FORMALIN CONCENT, a Formalin, Neutral Buffered (Class I — General Controls, product code IFP), submitted by Surgipath (Mchenry, US). The FDA issued a Cleared decision on December 10, 1981, 51 days after receiving the submission on October 20, 1981. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K812940 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1981
Decision Date December 10, 1981
Days to Decision 51 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