Cleared Traditional

CB FORMALIN

K842862 · Anatech, Ltd. · Pathology
Aug 1984
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K842862 is an FDA 510(k) clearance for the CB FORMALIN, a Solution, Formalin Ammonium Bromide (Class I — General Controls, product code IGE), submitted by Anatech, Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1984, 36 days after receiving the submission on July 23, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K842862 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1984
Decision Date August 28, 1984
Days to Decision 36 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IGE — Solution, Formalin Ammonium Bromide
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010