Cleared Traditional

PRO-PAR CLEARANT

K842861 · Anatech, Ltd. · Pathology
Aug 1984
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K842861 is an FDA 510(k) clearance for the PRO-PAR CLEARANT, a Agent, Clearing (Class I — General Controls, product code KEM), submitted by Anatech, Ltd. (Mchenry, US). The FDA issued a Cleared decision on August 21, 1984, 29 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 K842861 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1984
Decision Date August 21, 1984
Days to Decision 29 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KEM — Agent, Clearing
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.4010