Monitemp Blood Pack Temp. Monitor

FDA 510(k) K800667 · Liquid Crystal Products, Inc.

Substantially Equivalent

510(k) numberK800667

Submission

Device name
Monitemp Blood Pack Temp. Monitor
Applicant
Liquid Crystal Products, Inc.
Walker, MI, US
Received
March 26, 1980
Decision date
April 16, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KSE – Refrigerator, Freezer, Blood Storage
Device class
Class II (moderate risk)
Regulation
21 CFR 864.9700
Specialty
Hematology

Other 510(k)s with product code KSE

510(k)DeviceApplicantDecision
K884436Modified Low-Temp. Freezer Model HLT-80LS-85KSE · Traditional Harris Mfg. Co.12/02/1988SE
K813327Sepcor Temperature MonitorKSE · Traditional Separation Science Corp.12/31/1981SE
K802319Hemotemp TMKSE · Traditional Marion Laboratories, Inc.10/10/1980SE

More from Marion Laboratories, Inc.

510(k)DeviceDecision
K821312Temptrend Temperature Trend IndicatorKPD · Traditional 05/28/1982SE
K800666Quik-TempKPP · Traditional 05/08/1980SE

Questions and answers

When was Monitemp Blood Pack Temp. Monitor cleared by the FDA?

Monitemp Blood Pack Temp. Monitor (K800667) received a 510(k) decision of Substantially Equivalent on April 16, 1980, 21 days after the submission was received.

What is the product code of K800667?

The FDA product code is KSE – Refrigerator, Freezer, Blood Storage, a Class II (moderate risk) device regulated under 21 CFR 864.9700.