Product code KSF— Hematology

FDA has cleared 12 devices under product code KSF between 1977 and 1981, filed by 11 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.

• 19812 clearances
• 19804 clearances
• 19792 clearances
• 19782 clearances
• 19772 clearances

• Ortho Diagnostics, Inc.2 clearances
• Ortho Diagnostic Systems, Inc.1 clearance
• North American Biologicals, Inc.1 clearance
• Hyland Therapeutic Div., Travenol Laboratories1 clearance
• Gotham Biologics, Inc.1 clearance
• Gamma Biologicals, Inc.1 clearance
• Diagnostic Technology, Inc.1 clearance
• Dade, Baxter Travenol Diagnostics, Inc.1 clearance
• Bd Becton Dickinson Vacutainer Systems Preanalytic1 clearance
• Bca Biological Corp. of America1 clearance

• K811713 — AVI-D CONTROLOrtho Diagnostic Systems, Inc.·1981-10-23
• K810599 — DADE RH CONTROL REAGENTAmerican Dade·1981-03-31
• K801425 — RH CONTROLNorth American Biologicals, Inc.·1980-07-14
• K800658 — RST-SERIES CONTROLGamma Biologicals, Inc.·1980-04-16
• K800310 — ORTHO ANTISERA CONTROLOrtho Diagnostics, Inc.·1980-03-05
• K800239 — RH-HR NEGATIVE CONTROL REAGENTGotham Biologics, Inc.·1980-02-21
• K790249 — TEST CELLSHyland Therapeutic Div., Travenol Laboratories·1979-05-16
• K790025 — COUNTER CHECK, H001, H002, H003Diagnostic Technology, Inc.·1979-01-17
• K780665 — RECAPBca Biological Corp. of America·1978-06-06
• K780097 — QUALITY CONTROL SYSTEM, SPECTRABd Becton Dickinson Vacutainer Systems Preanalytic·1978-04-24
• K771814 — REAGENT CONFIDENCE SERAOrtho Diagnostics, Inc.·1977-11-07
• K761284 — UNIVAL CONTROL CELLSDade, Baxter Travenol Diagnostics, Inc.·1977-01-25