Cleared Traditional

FORMALIN BUFFERED

K842982 · Reagent Laboratory, Inc. · Pathology
Oct 1984
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K842982 is an FDA 510(k) clearance for the FORMALIN BUFFERED, a Formalin, Neutral Buffered (Class I — General Controls, product code IFP), submitted by Reagent Laboratory, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984, 63 days after receiving the submission on July 30, 1984. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K842982 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 1984
Decision Date October 01, 1984
Days to Decision 63 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