Cleared Traditional

ULTRAFREE CALCIUM FILTER

K801500 · Millipore Corp. · Chemistry
Aug 1980
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K801500 is an FDA 510(k) clearance for the ULTRAFREE CALCIUM FILTER, a Unit, Filter, Membrane (Class I — General Controls, product code JRL), submitted by Millipore Corp. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980, 54 days after receiving the submission on June 27, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K801500 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 1980
Decision Date August 20, 1980
Days to Decision 54 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