Product code KSQ— Hematology

FDA has cleared 8 devices under product code KSQ between 1976 and 1984, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19841 clearance
• 19821 clearance
• 19812 clearances
• 19802 clearances
• 19781 clearance
• 19761 clearance

• Lifeline Instruments, Inc.2 clearances
• Helmer Labs, Inc.2 clearances
• Travenol Laboratories, S.A.1 clearance
• Separation Science Corp.1 clearance
• Royco Instruments1 clearance
• R&D Systems, Inc.1 clearance

• K842746 — HYCEL ROTOR-MIXER AND/OR MULTIR&D Systems, Inc.·1984-08-17
• K820712 — SEPCOR UNIT COLLECTION MONITORSeparation Science Corp.·1982-05-07
• K812533 — PLATELET AGITATORHelmer Labs, Inc.·1981-09-29
• K810617 — MOBILE MATIC AUTOMATIC DONOR SCALELifeline Instruments, Inc.·1981-04-07
• K802608 — HEMATIC BLOOD MIXERHelmer Labs, Inc.·1980-12-11
• K800104 — ROYCO MODEL 951 CELL MIXERRoyco Instruments·1980-02-06
• K780189 — PLATELET ROTATORTravenol Laboratories, S.A.·1978-03-30
• K760743 — DONORMATIC (BLOOD COLLECTION DEVICE)Lifeline Instruments, Inc.·1976-12-06