Cleared Traditional

NBF 10% NEUTRAL BUFFERED FORMALIN

K870852 · Anatech, Ltd. · Pathology
Mar 1987
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K870852 is an FDA 510(k) clearance for the NBF 10% NEUTRAL BUFFERED FORMALIN, a Formalin, Neutral Buffered (Class I — General Controls, product code IFP), submitted by Anatech, Ltd. (Battle Creek, US). The FDA issued a Cleared decision on March 31, 1987, 28 days after receiving the submission on March 3, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K870852 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 1987
Decision Date March 31, 1987
Days to Decision 28 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