KSE — Refrigerator, Freezer, Blood Storage Class II

FDA Device Classification

Classification Details

Product Code
KSE
Device Class
Class II
Regulation Number
864.9700
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K884436harris mfgMODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85December 2, 1988
K813327separation scienceSEPCOR TEMPERATURE MONITORDecember 31, 1981
K802319marion laboratoriesHEMOTEMP TMOctober 10, 1980
K800667liquid crystal productsMONITEMP BLOOD PACK TEMP. MONITORApril 16, 1980