Cleared Traditional

K800666 - QUIK-TEMP
(FDA 510(k) Clearance)

K800666 · Liquid Crystal Products, Inc. · Gastroenterology & Urology
May 1980
Decision
43d
Days
Class 2
Risk

K800666 is an FDA 510(k) clearance for the QUIK-TEMP, a Peritoneal Dialysate Filter (Class II — Special Controls, product code KPP), submitted by Liquid Crystal Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1980, 43 days after receiving the submission on March 26, 1980. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K800666 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1980
Decision Date May 08, 1980
Days to Decision 43 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KPP — Peritoneal Dialysate Filter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630