Cleared Traditional

CBA FORMALIN

K842940 · Anatech, Ltd. · Pathology
Aug 1984
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K842940 is an FDA 510(k) clearance for the CBA FORMALIN, a Formalin, Neutral Buffered (Class I — General Controls, product code IFP), submitted by Anatech, Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1984, 34 days after receiving the submission on July 25, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K842940 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1984
Decision Date August 28, 1984
Days to Decision 34 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