Cleared Traditional

MONITEMP BLOOD PACK TEMP. MONITOR

K800667 · Liquid Crystal Products, Inc. · Hematology
Apr 1980
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K800667 is an FDA 510(k) clearance for the MONITEMP BLOOD PACK TEMP. MONITOR, a Refrigerator, Freezer, Blood Storage (Class II — Special Controls, product code KSE), submitted by Liquid Crystal Products, Inc. (Walker, US). The FDA issued a Cleared decision on April 16, 1980, 21 days after receiving the submission on March 26, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.9700.

Submission Details

510(k) Number K800667 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 1980
Decision Date April 16, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary

Device Classification

Product Code KSE — Refrigerator, Freezer, Blood Storage
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.9700