Product code KSA— Hematology

FDA has cleared 8 devices under product code KSA between 1982 and 1994, filed by 6 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.

• 19941 clearance
• 19901 clearance
• 19881 clearance
• 19871 clearance
• 19861 clearance
• 19851 clearance
• 19822 clearances

• R&D Systems, Inc.3 clearances
• Technicon Instruments Corp.1 clearance
• Streck Laboratories, Inc.1 clearance
• Hematology Marketing Assoc.1 clearance
• Coulter Electronics, Inc.1 clearance
• American Dade1 clearance

• K943268 — SCS-1000 (SYSMEX CALIBRATOR SYSTEM)Streck Laboratories, Inc.·1994-12-15
• K897060 — CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLER&D Systems, Inc.·1990-01-02
• K881161 — TECH-CAL(TM)/MULTIPLER&D Systems, Inc.·1988-05-02
• K864664 — H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORSTechnicon Instruments Corp.·1987-02-06
• K854823 — CBC-CAL/MULTIPLER&D Systems, Inc.·1986-02-13
• K844708 — TRI-COUNT CALIBRATORHematology Marketing Assoc.·1985-03-05
• K813530 — HEMOTOLOGY CALIBRATORAmerican Dade·1982-02-22
• K813375 — HEMATOLOGY CALIBRATOR S-CALCoulter Electronics, Inc.·1982-02-04