Cleared Traditional

ACRO PACK

K822121 · Gelman Sciences, Inc. · Chemistry
Aug 1982
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K822121 is an FDA 510(k) clearance for the ACRO PACK, 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 August 5, 1982, 17 days after receiving the submission on July 19, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K822121 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1982
Decision Date August 05, 1982
Days to Decision 17 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