Cleared Traditional

ACRODISC

K810829 · Gelman Sciences, Inc. · Chemistry
Apr 1981
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K810829 is an FDA 510(k) clearance for the ACRODISC, a Unit, Filter, Membrane (Class I — General Controls, product code JRL), submitted by Gelman Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1981, 14 days after receiving the submission on March 25, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K810829 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 1981
Decision Date April 08, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JRL — Unit, Filter, Membrane
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050