Product code KSS— Hematology

FDA has cleared 6 devices under product code KSS between 1976 and 1988, filed by 4 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.

• 19881 clearance
• 19811 clearance
• 19803 clearances
• 19761 clearance

• Pre-Dent System3 clearances
• U.S. Mfg. & Management, Inc.1 clearance
• Dade, Baxter Travenol Diagnostics, Inc.1 clearance
• American Dade1 clearance

• K874436 — FLUID SAMPLING PACKU.S. Mfg. & Management, Inc.·1988-01-05
• K812892 — S/P SERUM DROPPER PIPETSAmerican Dade·1981-10-27
• K801386 — PRE-DENT SYSTEM OR PRE-DENT IIPre-Dent System·1980-07-14
• K801516 — PRE-DENT SYSTEM MODIFIEDPre-Dent System·1980-07-14
• K800736 — PRE-DENT SYSTEMPre-Dent System·1980-04-24
• K761303 — IMMU-SAL IMMUNOHEMATOLOGICAL SALINEDade, Baxter Travenol Diagnostics, Inc.·1976-12-30