FDA.reportPublic FDA data

510(k) K800667

Device
MONITEMP BLOOD PACK TEMP. MONITOR
Applicant
LIQUID CRYSTAL PRODUCTS, INC.
510(k) number
K800667
Product code
KSE  
Decision
Substantially Equivalent (SESE)
Decision date
1980-04-16
Date received
1980-03-26
Regulation
864.9700
Classification name
Refrigerator, Freezer, Blood Storage
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KSE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884436MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85Harris Mfg. Co.1988-12-02
K813327SEPCOR TEMPERATURE MONITORSeparation Science Corp.1981-12-31
K802319HEMOTEMP TMMarion Laboratories, Inc.1980-10-10

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases