Product code KSX— Hematology

FDA has cleared 8 devices under product code KSX between 1977 and 1980, 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.

• 19803 clearances
• 19783 clearances
• 19772 clearances

• North American Biologicals, Inc.3 clearances
• Ortho Diagnostics, Inc.2 clearances
• Gamma Biologicals, Inc.2 clearances
• Travenol Laboratories, S.A.1 clearance

• K802533 — GAMMA LEWIS BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.·1980-11-12
• K802534 — GAMMA PI BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.·1980-11-12
• K800916 — P1 BLOOD GROUP SUBSTANCETravenol Laboratories, S.A.·1980-05-08
• K781862 — BLOOD GROUP SUBSTANCE ANorth American Biologicals, Inc.·1978-12-20
• K781895 — BLOOD GROUP SUBSTANCE BNorth American Biologicals, Inc.·1978-12-20
• K781896 — BLOOD GROUP SUBSTANCE A,BNorth American Biologicals, Inc.·1978-12-20
• K771487 — LEWIS BLOOD GROUP SUBSTANCEOrtho Diagnostics, Inc.·1977-11-08
• K771488 — P1 BLOOD GROUP SUBSTANCEOrtho Diagnostics, Inc.·1977-11-08