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FDA Product Code

FDA Product Code KSE — Clearance Directory

Device Class
Class II
Assigned Panel
Hematology
21 CFR Citation
864.9700

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K884436 MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 Harris Mfg. Co. 1988-12-02 Traditional PDF ↗
K813327 SEPCOR TEMPERATURE MONITOR Separation Science Corp. 1981-12-31 Traditional PDF ↗
K802319 HEMOTEMP TM Marion Laboratories, Inc. 1980-10-10 Traditional PDF ↗
K800667 MONITEMP BLOOD PACK TEMP. MONITOR Liquid Crystal Products, Inc. 1980-04-16 Traditional PDF ↗

Product code KSE · Class II · Hematology. Data: openFDA.