Product code KSE— Hematology

FDA has cleared 4 devices under product code KSE between 1980 and 1988, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19881 clearance
• 19811 clearance
• 19802 clearances

• Separation Science Corp.1 clearance
• Marion Laboratories, Inc.1 clearance
• Liquid Crystal Products, Inc.1 clearance
• Harris Mfg. Co.1 clearance

• K884436 — MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85Harris Mfg. Co.·1988-12-02
• K813327 — SEPCOR TEMPERATURE MONITORSeparation Science Corp.·1981-12-31
• K802319 — HEMOTEMP TMMarion Laboratories, Inc.·1980-10-10
• K800667 — MONITEMP BLOOD PACK TEMP. MONITORLiquid Crystal Products, Inc.·1980-04-16